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FDA 510(k) Application Details - K173771
Device Classification Name
Biomicroscope, Slit-Lamp, Ac-Powered
More FDA Info for this Device
510(K) Number
K173771
Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Applicant
Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
Jena 07445 DE
Other 510(k) Applications for this Company
Contact
Christian Muenster
Other 510(k) Applications for this Contact
Regulation Number
886.1850
More FDA Info for this Regulation Number
Classification Product Code
HJO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/11/2017
Decision Date
08/24/2018
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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