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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tonometer, manual
510(k) Number K945541
Device Name SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE
Applicant
RUDOLF RIESTER GMBH & CO. KG
POSTFACH 35
BRUCKSTRABE 31
D-72417 JUNGINGEN,  DE
Applicant Contact KARLHEINZ RIESR P RESIDENT
Correspondent
RUDOLF RIESTER GMBH & CO. KG
POSTFACH 35
BRUCKSTRABE 31
D-72417 JUNGINGEN,  DE
Correspondent Contact KARLHEINZ RIESR P RESIDENT
Regulation Number886.1930
Classification Product Code
HKY  
Date Received11/10/1994
Decision Date 05/08/1995
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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