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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K133562
Device Name CATARHEX 3
Applicant
Oertli Instrumente AG
Hafnerwisenstrasse 4
Berneck,  CH 9442
Applicant Contact KARIN ROHR
Correspondent
Oertli Instrumente AG
Hafnerwisenstrasse 4
Berneck,  CH 9442
Correspondent Contact KARIN ROHR
Regulation Number886.4670
Classification Product Code
HQC  
Subsequent Product Codes
GEI   HQE  
Date Received11/20/2013
Decision Date 08/12/2014
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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