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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 St. 29
Wetzlar,  DE D-35582
Applicant Contact ECKHARD LOH
Correspondent
Oculus Optikgerate GmbH
Munchholzhauser St. 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
Predetermined Change
Control Plan Authorized		 No
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