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FDA 510(k) Application Details - K200056
Device Classification Name
Ophthalmic Femtosecond Laser
More FDA Info for this Device
510(K) Number
K200056
Device Name
Ophthalmic Femtosecond Laser
Applicant
AMO Manufacturng USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035 US
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Contact
Laarni Ricafort
Other 510(k) Applications for this Contact
Regulation Number
886.4390
More FDA Info for this Regulation Number
Classification Product Code
OOE
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More FDA Info for this Product Code
Date Received
01/13/2020
Decision Date
05/18/2020
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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