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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 K945870
Device Name R&D PART NOS. 5490, 5541, 5358, 5497
Applicant
R & D BATTERIES, INC.
P.O. BOX 5007
BURNSVILLE,  MN  55337
Applicant Contact RANDALL C NODDINGS
Correspondent
R & D BATTERIES, INC.
P.O. BOX 5007
BURNSVILLE,  MN  55337
Correspondent Contact RANDALL C NODDINGS
Regulation Number876.1500
Classification Product Code
FCO  
Date Received12/01/1994
Decision Date 03/23/1995
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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