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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Powered
510(k) Number K935467
Device Name R & D BATTERIES, INC. PART NUMBER 5447
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 Number890.5380
Classification Product Code
BXB  
Date Received11/01/1993
Decision Date 04/19/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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