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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name First Aid Kit With Drug
510(k) Number K871501
Device Name KIT, FIRST AID, GENERAL PURPOSE, RIGID CASE
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
LRR  
Date Received04/17/1987
Decision Date 06/02/1987
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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