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FDA 510(k) Application Details - K173371
Device Classification Name
Keratome, Ac-Powered
More FDA Info for this Device
510(K) Number
K173371
Device Name
Keratome, Ac-Powered
Applicant
Carl Zeiss Meditec, Inc.
5160 Hacienda Drive
Dublin, CA 94568 US
Other 510(k) Applications for this Company
Contact
Todd Otani
Other 510(k) Applications for this Contact
Regulation Number
886.4370
More FDA Info for this Regulation Number
Classification Product Code
HNO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/27/2017
Decision Date
04/13/2018
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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