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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 K863714
Device Name BANDAGE, GAUZE, SIX-PLY, VARIOUS SIZES
Applicant
Fraass Survival Systems, Inc.
3830 Boston Rd.
Bronx,  NY  10475
Applicant Contact PATRICK A MALIA
Correspondent
Fraass Survival Systems, Inc.
3830 Boston Rd.
Bronx,  NY  10475
Correspondent Contact PATRICK A MALIA
Classification Product Code
EFQ  
Date Received09/23/1986
Decision Date 10/14/1986
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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