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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinometer, Mechanical
510(k) Number K870240
Device Name COMPRESS AND SKULLCAP, HEAD 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
Regulation Number876.1800
Classification Product Code
EXR  
Date Received01/21/1987
Decision Date 02/20/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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