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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 K871916
Device Name FRASTEC DRY BURN DRESSING
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 Received05/18/1987
Decision Date 06/16/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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