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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 K950914
Device Name RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAESTHETIC MODEL 2,5 V/220 V OR 110 C 3,5 V/V
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 Received02/23/1995
Decision Date 07/24/1995
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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