DYNAREX DRAIN SPONGE


Device Classification Name

bandage, liquid

510(k) Number K991694
Device Name DYNAREX DRAIN SPONGE
Applicant
DYNAREX CORP.
one international blvd.
brewster, 
NY 
10509

Applicant Contact john g moulden
Correspondent
DYNAREX CORP.
one international blvd.
brewster, 
NY 
10509

Correspodent Contact john g moulden
Regulation Number 880.5090
Classification Product Code
KMF  
Date Received 05/18/1999
Decision Date 07/15/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General & Plastic Surgery

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No