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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Occlusive
510(k) Number K854850
Device Name FALKON STRETCH-STERILE
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
Regulation Number878.4020
Classification Product Code
NAD  
Date Received12/04/1985
Decision Date 01/13/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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