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FDA 510(k) Application Details - K120426
Device Classification Name
Ophthalmic Femtosecond Laser
More FDA Info for this Device
510(K) Number
K120426
Device Name
Ophthalmic Femtosecond Laser
Applicant
TECHNOLAS PERFECT VISION GMBH
1025 SANCHEZ STREET
SAN FRANCISCO, CA 94114 US
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Contact
KEN NEHMER
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
02/13/2012
Decision Date
07/31/2012
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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