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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 K193376
Device Name Visalis V500, Visalis S500
Applicant
Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
Jena,  DE 07745
Applicant Contact Katrin Faber
Correspondent
Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
Jena,  DE 07745
Correspondent Contact Katrin Faber
Regulation Number886.4670
Classification Product Code
HQC  
Date Received12/05/2019
Decision Date 06/15/2020
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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