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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retinoscope, Battery-Powered
510(k) Number K964338
Device Name RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT
Applicant
Rudolf Riester GmbH & Co. KG
Postfach 35
Bruckstrabe 31
D-72417 Jungingen,  DE
Applicant Contact PATRICIA RIESTER-FREUDENMANN
Correspondent
Rudolf Riester GmbH & Co. KG
Postfach 35
Bruckstrabe 31
D-72417 Jungingen,  DE
Correspondent Contact PATRICIA RIESTER-FREUDENMANN
Regulation Number886.1780
Classification Product Code
HKM  
Date Received10/31/1996
Decision Date 01/09/1997
Decision Substantially Equivalent (SESE)
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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