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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 K953810
Device Name FLUFF GAUZE BANDAGE, STERILE & NON-STERILE
Applicant
K. W. Griffen Co.
100 Pearl St.
Norwalk,  CT  06850
Applicant Contact DAVID M PIERATOS
Correspondent
K. W. Griffen Co.
100 Pearl St.
Norwalk,  CT  06850
Correspondent Contact DAVID M PIERATOS
Classification Product Code
EFQ  
Date Received08/08/1995
Decision Date 09/14/1995
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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