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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Multipurpose For In Vitro Coagulation Studies
510(k) Number K934747
Device Name R & D BATTERIES, INC. PART NUMBERS 5296, 5479, 5351, & 5470
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 Number864.5425
Classification Product Code
JPA  
Date Received10/04/1993
Decision Date 12/03/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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