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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 K864011
Device Name EXU-DRY BURN/TRAUMA DRESSING, 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
Regulation Number878.4020
Classification Product Code
NAD  
Date Received10/15/1986
Decision Date 11/22/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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