FDA 510(k) Premarket Notification K961841: BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06)

Submission Details & Decision

Normalized public record details for 510(k) notification K961841.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K961841

Applicant / Sponsor

C.R. Bard, Inc.

Device Name

BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06)

Product Code

FAS

Decision Date

1996-10-09

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Gastroenterology, Urology (GU)

Clearance Type

Traditional

Third Party Flag

Date Received

1996-05-13

Related Establishments / Registrations

C.R. BARD, INC. Registration: 1018233 View Registration
DORNIER MEDTECH AMERICA, INC. Registration: 1037955 View Registration
Sterigenics U.S. LLC Registration: 1054811 View Registration
RG Medical USA Registration: 1057358 View Registration
Sterigenics U.S., LLC Registration: 1319639 View Registration
RICHARD WOLF MEDICAL INSTRUMENTS CORP. Registration: 1418479 View Registration
MEDLINE INDUSTRIES, LP (Northpoint Services) Registration: 1422634 View Registration
Sterigenics US LLC Registration: 1649518 View Registration
GRACE MANUFACTURING INC Registration: 1651252 View Registration
KARL STORZ ENDOSCOPY-AMERICA, INC. Registration: 2020550 View Registration
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. Registration: 2085947 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
ACTEON, INC. Registration: 2243757 View Registration
LYNX Medical NJ Registration: 2244478 View Registration
FLEXBAR MACHINE CORP. Registration: 2424366 View Registration
Sklar Corporation Registration: 2431166 View Registration
STRYKER ENDOSCOPY Registration: 2936485 View Registration
Synergy Health Sterilisation UK Ltd Registration: 3002807310 View Registration
ASAHI INTECC (THAILAND) CO., LTD. Registration: 3003780911 View Registration
GYRUS ACMI, INC. Registration: 3003790304 View Registration
Sterigenics US LLC Registration: 3004111573 View Registration
MILLENNIUM SURGICAL CORP Registration: 3004215117 View Registration
AMERICAN MEDICAL ENDOSCOPY Registration: 3004361445 View Registration
STERIS AST CZ s.r.o. Registration: 3004784537 View Registration
COOK MEDICAL LLC Registration: 3005580113 View Registration
C.R. BARD, INC. Registration: 3006082230 View Registration
KARL STORZ SE & CO. KG Registration: 3006546082 View Registration
Olympus Medical Products Czech Registration: 3007960282 View Registration
Olympus Vietnam Co. Ltd. Registration: 3008040402 View Registration
Sterigenics UK Limited Registration: 3008132398 View Registration
STRYKER EMEA Supply Chain Services Registration: 3008837339 View Registration
Eurofins STERIPAC GMBH Registration: 3009217531 View Registration
Primo Medical Group, Inc Registration: 3009420598 View Registration
Karl Storz Endoscopy-America, Inc. Registration: 3010202439 View Registration
STERISERVICES Registration: 3010383847 View Registration
INVIDIA MEDICAL GMBH U CO KG Registration: 3010399422 View Registration
KARL STORZ SE & CO. KG Registration: 3010707607 View Registration
Gyrus ACMI, Inc. Registration: 3011050570 View Registration
Pacific Surgical Specialties Registration: 3011586151 View Registration
ACE MEDICAL DEVICES PVT. LTD Registration: 3011987935 View Registration
MYSORE WIFILTRONICS PVT. LTD Registration: 3011989678 View Registration
KARL STORZ ENDOSCOPY CANADA LTD. Registration: 3012322232 View Registration
MED CONTACT GMBH Registration: 3012460907 View Registration
MAHE MEDICAL USA Registration: 3013011598 View Registration
Arvato SE Registration: 3013247477 View Registration
KARL STORZ SE & CO KG Registration: 3014342096 View Registration
AMNOTEC INTERNATIONAL MEDICAL GMBH Registration: 3014615697 View Registration
Aomori Olympus Co., Ltd. Hirosaki Site Registration: 3014769442 View Registration
Lamidey Noury Medical Registration: 3015286855 View Registration
Sklar Corporation - Warehouse Registration: 3015895045 View Registration
MDTGLOBAL, A.S. Registration: 3024021261 View Registration
MEDCARE SOLUTIONS GMBH Registration: 3031240334 View Registration
YIXIN PRECISION ENGINEERING PTE LTD Registration: 3042471321 View Registration
OLYMPUS MEDICAL SYSTEMS CORP. Registration: 8010047 View Registration
HENKE-SASS WOLF, GMBH. Registration: 8010418 View Registration
KOSCHER & WUERTZ GMBH Registration: 8010877 View Registration
ERBE ELEKTROMEDIZIN GMBH Registration: 9610614 View Registration
KARL STORZ SE & CO. KG Registration: 9610617 View Registration
OLYMPUS WINTER & IBE GMBH Registration: 9610773 View Registration
RICHARD WOLF GMBH Registration: 9611102 View Registration
TEKNO MEDICAL OPTIK-CHIRURGIE GMBH Registration: 9611503 View Registration
PRODUCTOS PARA EL CUIDADO DE LA SALUD Registration: 9611590 View Registration
AOMORI OLYMPUS CO., LTD. Kuroishi Site Registration: 9614641 View Registration
BOWA-ELECTRONIC GMBH & CO. KG Registration: 9614969 View Registration
GYRUS MEDICAL LTD. Registration: 9617070 View Registration
TONTARRA MEDIZINTECHNIK GMBH Registration: 9680515 View Registration
RZ MEDIZINTECHNIK GMBH Registration: 9680718 View Registration

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