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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 K932504
Device Name RI-FORMER
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  
Date Received05/21/1993
Decision Date 10/15/1993
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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