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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 K945640
Device Name RI-SCOPE S OTOSCOPE
Applicant
RUDOLF RIESTER GMBH & CO. KG
POSTFACH 35
BRUCKSTRABE 31
D-72417 JUNGINGEN,  DE
Applicant Contact KARLHEINZ RIESTER
Correspondent
RUDOLF RIESTER GMBH & CO. KG
POSTFACH 35
BRUCKSTRABE 31
D-72417 JUNGINGEN,  DE
Correspondent Contact KARLHEINZ RIESTER
Regulation Number886.1570
Classification Product Code
HLJ  
Subsequent Product Code
ERA  
Date Received11/16/1994
Decision Date 01/17/1995
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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