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FDA 510(k) Application Details - K103056
Device Classification Name
Laser, Ophthalmic
More FDA Info for this Device
510(K) Number
K103056
Device Name
Laser, Ophthalmic
Applicant
CARL ZEISS MEDITEC AG
5160 HACIENDA DRIVE
DUBLIN, CA 94568 US
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Contact
JUDITH A BRIMACOMBE
Other 510(k) Applications for this Contact
Regulation Number
886.4390
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Classification Product Code
HQF
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More FDA Info for this Product Code
Date Received
10/15/2010
Decision Date
02/01/2011
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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