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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thermometer, Electronic, Clinical
510(k) Number K951282
Device Name R&D BATTERIES, INC. PART NUMBERS 5039, 5052, 5056 AND 5061
Applicant
R & D BATTERIES, INC.
400 GATEWAY BLVD.
BURNSVILLE,  MN  55337
Applicant Contact RANDALL C NODDINGS
Correspondent
R & D BATTERIES, INC.
400 GATEWAY BLVD.
BURNSVILLE,  MN  55337
Correspondent Contact RANDALL C NODDINGS
Regulation Number880.2910
Classification Product Code
FLL  
Subsequent Product Code
FRW  
Date Received03/21/1995
Decision Date 08/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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