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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, monitoring, perinatal
510(k) Number K935377
Device Name R AND D BATTERIES
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 Number884.2740
Classification Product Code
HGM  
Date Received11/08/1993
Decision Date 12/05/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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