FDA 510(k) Premarket Notification K954741: DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)

Submission Details & Decision

Normalized public record details for 510(k) notification K954741.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K954741

Applicant / Sponsor

Derma Sciences, Inc.

Device Name

DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)

Product Code

MGQ

Decision Date

1995-11-01

Decision / Status

Substantially Equivalent for Some Indications (SN)

Advisory Committee

Unknown ()

Clearance Type

Traditional

Third Party Flag

Date Received

1995-10-16

Related Establishments / Registrations

Cardinal Health Registration: 1018120 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1034876 View Registration
Sterigenics U.S., LLC Registration: 1036836 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1043214 View Registration
DeRoyal Industries, Inc. Registration: 1054241 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1055236 View Registration
Sterigenics US LLC Registration: 1058584 View Registration
Sterigenics U.S., LLC Registration: 1061124 View Registration
SPAN PACKAGING SERVICES d.b.a. MULTI-PACK SOLUTIONS Registration: 1063707 View Registration
Cardinal Health Registration: 1219103 View Registration
Water-Jel Technologies, LLC Registration: 1219592 View Registration
MEDLINE INDUSTRIES, LP - Northfield Registration: 1417592 View Registration
FERRIS MFG. CORP. Registration: 1419520 View Registration
Cardinal Health 200, LLC Registration: 1423537 View Registration
MPM MEDICAL Registration: 1646434 View Registration
Sterigenics US LLC Registration: 1649518 View Registration
Swiss-American CDMO,LLC Registration: 1649690 View Registration
Cardinal Health Registration: 1921846 View Registration
Sterigenics U.S., LLC Registration: 2029275 View Registration
Medline Industries, LP Registration: 2125337 View Registration
Stellen Medical, LLC Registration: 2132242 View Registration
L&R USA INC. Registration: 2135152 View Registration
DEROYAL INDUSTRIES, INC. Registration: 2320762 View Registration
DERMA SCIENCES NANTONG INCORPORATION Registration: 3003636207 View Registration
DMB Registration: 3005465238 View Registration
BIOKOSMES SRL Registration: 3005488444 View Registration
PHARMPUR GMBH Registration: 3005689226 View Registration
PRIMUS PHARMACEUTICALS, INC. Registration: 3006052875 View Registration
BIOMED LABORATORIES LLC Registration: 3006784948 View Registration
Molnlycke Health Care AB Registration: 3007048057 View Registration
HUMAN BIOSCIENCES, INC. Registration: 3008770963 View Registration
Synergy Health AST, LLC Registration: 3009882464 View Registration
FORWARD SCIENCE TECHNOLOGIES LLC Registration: 3010143501 View Registration
Synergy Sterilisation South Africa Proprietary Ltd Registration: 3010287685 View Registration
Virchow Biotech Pvt. Ltd. Registration: 3010315629 View Registration
BIOSTECH CO., LTD. Registration: 3011276993 View Registration
3-D MATRIX EUROPE SAS Registration: 3012263097 View Registration
Amerx Healthcare Corp Registration: 3012535730 View Registration
AIM MEDICAL INC Registration: 3012979524 View Registration
VEENAK INTERNATIONAL LIMITED Registration: 3013298431 View Registration
CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration
WORLDWIDE SUPPLIES LIMITED Registration: 3014579161 View Registration
3-D MATRIX, INC. Registration: 3015528146 View Registration
TBM CORPORATION Registration: 3016096134 View Registration
Lindo Manufacturing Registration: 3023548698 View Registration
Carowinds Registration: 3024971708 View Registration
BURNSHIELD (PTY) LTD. Registration: 8044046 View Registration
FIDIA FARMACEUTICI SPA Registration: 9610200 View Registration
COLOPLAST A/S Registration: 9610694 View Registration
DERMA SCIENCES CANADA, INC (dba DERMA SCIENCES, INC.) Registration: 9680091 View Registration
STERIS Applied Sterilization Technologies ULC Registration: 9680143 View Registration

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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.