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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Box, Battery, Pocket
510(k) Number K881885
Device Name BATTERY PACKS (OTHER THAN CV)
Applicant
DOWIT SERVICE CO., INC.
10 VALHALLA RD.
MONTVILLE,  NJ  07045
Applicant Contact JOAN POTOSNAK
Correspondent
DOWIT SERVICE CO., INC.
10 VALHALLA RD.
MONTVILLE,  NJ  07045
Correspondent Contact JOAN POTOSNAK
Regulation Number876.1500
Classification Product Code
FCP  
Date Received05/04/1988
Decision Date 07/26/1988
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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