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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, Rechargeable
510(k) Number K943632
Device Name REPLACEMENT BATTERIES
Applicant
NATIONAL CUSTOM ENT., INC.
400 GATEWAY BLVD.
BURNSVILLE,  MN  55337 -2559
Applicant Contact MICHAEL A BENYO
Correspondent
NATIONAL CUSTOM ENT., INC.
400 GATEWAY BLVD.
BURNSVILLE,  MN  55337 -2559
Correspondent Contact MICHAEL A BENYO
Regulation Number876.1500
Classification Product Code
FCO  
Date Received07/26/1994
Decision Date 11/04/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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