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FDA 510(k) Application Details - K093521
Device Classification Name
Ophthalmoscope,Laser,Scanning
More FDA Info for this Device
510(K) Number
K093521
Device Name
Ophthalmoscope,Laser,Scanning
Applicant
CARL ZEISS MEDITEC INC
5160 HACIENDA DR.
DUBLIN, CA 94551 US
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Contact
JUDY A BRIMACOMBE
Other 510(k) Applications for this Contact
Regulation Number
886.1570
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Classification Product Code
MYC
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More FDA Info for this Product Code
Date Received
11/13/2009
Decision Date
11/25/2009
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
Y
Expedited Review
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