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FDA 510(k) Application Details - K191194
Device Classification Name
More FDA Info for this Device
510(K) Number
K191194
Device Name
CLARUS
Applicant
Carl Zeiss Meditec, Inc
5160 Hacienda Drive
Dublin, CA 94568 US
Other 510(k) Applications for this Company
Contact
Saurabh Jamkhindikar
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QER
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More FDA Info for this Product Code
Date Received
05/03/2019
Decision Date
06/25/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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