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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Ultrasonic, Nonfetal
510(k) Number K935427
Device Name R AND D BATTERIES
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 Number892.1540
Classification Product Code
JAF  
Date Received11/10/1993
Decision Date 10/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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