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FDA 510(k) Application Details - K140615
Device Classification Name
Ophthalmic Femtosecond Laser
More FDA Info for this Device
510(K) Number
K140615
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
03/10/2014
Decision Date
07/15/2014
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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