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FDA 510(k) Application Details - K213559
Device Classification Name
Ophthalmic Femtosecond Laser
More FDA Info for this Device
510(K) Number
K213559
Device Name
Ophthalmic Femtosecond Laser
Applicant
SIE AG, Surgical Instrument Engineering
Allmendstrasse 11
Port CH-2502 CH
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Contact
Frank Ziemer
Other 510(k) Applications for this Contact
Regulation Number
886.4390
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Classification Product Code
OOE
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More FDA Info for this Product Code
Date Received
11/04/2021
Decision Date
04/21/2022
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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