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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 K870185
Device Name BANDAGE, GAUZE (NONABSOR. GAUZE FOR EXTERNAL USE)
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
Regulation Number878.4020
Classification Product Code
NAD  
Date Received01/16/1987
Decision Date 02/06/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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