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FDA 510(k) Application Details - K182659
Device Classification Name
Device,Analysis,Anterior Segment
More FDA Info for this Device
510(K) Number
K182659
Device Name
Device,Analysis,Anterior Segment
Applicant
SIS AG, Surgical Instrument Systems
Allmendstrasse 11
Port CH-2502 CH
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Contact
Frank Ziemer
Other 510(k) Applications for this Contact
Regulation Number
886.1850
More FDA Info for this Regulation Number
Classification Product Code
MXK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/25/2018
Decision Date
07/25/2019
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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