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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 K854432
Device Name FALKON STRETCH
Applicant
G.B.F. Industries, Inc.
119 W. 57th St.
New York,  NY  10019
Applicant Contact BERNARD FALK
Correspondent
G.B.F. Industries, Inc.
119 W. 57th St.
New York,  NY  10019
Correspondent Contact BERNARD FALK
Classification Product Code
EFQ  
Date Received11/05/1985
Decision Date 11/22/1985
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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