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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Battery-Powered
510(k) Number K936018
Device Name REPLACEMENT BATTERIES PART NO. 5098,5135, 5097
Applicant
R & D BATTERIES, INC.
2224 EAST 117TH ST.
P.O. BOX 5007
BURNSVILLE,  MN  55337
Applicant Contact RANDALL C NODDINGS
Correspondent
R & D BATTERIES, INC.
2224 EAST 117TH ST.
P.O. BOX 5007
BURNSVILLE,  MN  55337
Correspondent Contact RANDALL C NODDINGS
Regulation Number886.1570
Classification Product Code
HLJ  
Date Received12/16/1993
Decision Date 02/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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