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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal
510(k) Number K935257
Device Name MEDICOM NON-WOVEN SPONGES
Applicant
A.R. Medicom, Inc.
910 Rue Begin
St. Laurent,
Quebec, H4m 2n5 Canada,  CA H4M 2N5
Applicant Contact RONALD REUBEN
Correspondent
A.R. Medicom, Inc.
910 Rue Begin
St. Laurent,
Quebec, H4m 2n5 Canada,  CA H4M 2N5
Correspondent Contact RONALD REUBEN
Classification Product Code
EFQ  
Date Received11/01/1993
Decision Date 04/14/1994
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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