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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve
510(k) Number K933491
Device Name R AND D BATTERIES, INC. PART NOS. 5038 & 5347
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 Number874.1820
Classification Product Code
ETN  
Date Received07/15/1993
Decision Date 11/19/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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