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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, peritoneal, automatic delivery
510(k) Number K933687
Device Name R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260
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 Number876.5630
Classification Product Code
FKX  
Subsequent Product Codes
FAP   FKP  
Date Received07/29/1993
Decision Date 02/09/1994
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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