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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 K942018
Device Name R&D BATTERIES, PART NO. 5025, 5128 AND 5183
Applicant
R & D BATTERIES, INC.
2224 EAST 117TH ST.
P.O. BOX 5007
BURNSVILLE,  MN  55337
Applicant Contact RANDALL C NODDINGS
Correspondent
R & D BATTERIES, INC.
2224 EAST 117TH ST.
P.O. BOX 5007
BURNSVILLE,  MN  55337
Correspondent Contact RANDALL C NODDINGS
Regulation Number876.1500
Classification Product Code
FCO  
Date Received04/26/1994
Decision Date 07/25/1994
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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