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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tonometer, ac-powered
510(k) Number K113066
Device Name CORVIS ST
Applicant
OCULUS OPTIKGERATE GMBH
MUNCHHOLZHAUSER STR. 29
WETZLAR,  DE D-35582
Applicant Contact ECKHARD LOH
Correspondent
OCULUS OPTIKGERATE GMBH
MUNCHHOLZHAUSER STR. 29
WETZLAR,  DE D-35582
Correspondent Contact ECKHARD LOH
Regulation Number886.1930
Classification Product Code
HKX  
Subsequent Product Code
MXK  
Date Received10/17/2011
Decision Date 11/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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