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FDA 510(k) Application Details - K110427
Device Classification Name
Ophthalmic Femtosecond Laser
More FDA Info for this Device
510(K) Number
K110427
Device Name
Ophthalmic Femtosecond Laser
Applicant
TECHNOLAS PERFECT VISION GMBH
PO BOX 17190
ANAHEIM, CA 92817-7190 US
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Contact
BETTY M JOHNSON
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
02/14/2011
Decision Date
11/22/2011
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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