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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Otoscope
510(k) Number K925759
Device Name UNI I
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 Number874.4770
Classification Product Code
ERA  
Date Received11/13/1992
Decision Date 07/26/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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