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FDA 510(k) Application Details - K210827
Device Classification Name
More FDA Info for this Device
510(K) Number
K210827
Device Name
ZEPTO Precision Capsulotomy System
Applicant
Centricity Vision, Inc.
1939 Palomar Oaks Way, Suite A
Carlsbad, CA 92011 US
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Contact
Neal Hartman
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PUL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/19/2021
Decision Date
12/14/2021
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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