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FDA 510(k) Application Details - K200207
Device Classification Name
Unit, Phacofragmentation
More FDA Info for this Device
510(K) Number
K200207
Device Name
Unit, Phacofragmentation
Applicant
Carl Zeiss Meditec Cataract Technology Inc.
8748 Technology Way
Reno, NV 89521 US
Other 510(k) Applications for this Company
Contact
Gary Mocnik
Other 510(k) Applications for this Contact
Regulation Number
886.4670
More FDA Info for this Regulation Number
Classification Product Code
HQC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/28/2020
Decision Date
10/15/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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