FDA 510(k) Premarket Notification K121139: ACCUMESH DEPLOYMENT SYSTEM

Submission Details & Decision

Normalized public record details for 510(k) notification K121139.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K121139

Applicant / Sponsor

Covidien, LLC

Device Name

ACCUMESH DEPLOYMENT SYSTEM

Product Code

ORQ

Decision Date

2012-05-02

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

General, Plastic Surgery (SU)

Clearance Type

Special

Third Party Flag

Date Received

2012-04-16

Related Establishments / Registrations

Linvatec Corporation Registration: 1017294 View Registration
DAVOL INC., SUB. C.R. BARD, INC. Registration: 1213643 View Registration
Covidien Registration: 1219930 View Registration
Isomedix Operations Inc. Registration: 2246552 View Registration
COLLAGEN MATRIX, INC. Registration: 2249852 View Registration
SMITH & NEPHEW INC. Registration: 3003604053 View Registration
BARD SHANNON LIMITED Registration: 3005636544 View Registration
C.R. BARD, INC. Registration: 3006082230 View Registration
Synergy Health AST, SRL Registration: 3010273872 View Registration
Arthrocare Corporation Registration: 3012358417 View Registration
ORTA MEDICAL LTD Registration: 3013188547 View Registration
Schneider ASR B.V. Registration: 3016678045 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
IVUS ILAC SANAYI VE TICARET AS Registration: 3021632375 View Registration
Collagen Matrix, Inc. Registration: 3027448274 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.