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510(k) K193376

Visalis V500, Visalis S500 by Carl Zeiss Meditec, AG — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2020
Date Received
December 5, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type

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