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FDA 510(k) Application Details - K051789
Device Classification Name
Ophthalmoscope, Ac-Powered
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510(K) Number
K051789
Device Name
Ophthalmoscope, Ac-Powered
Applicant
CARL ZEISS MEDITEC INC
5160 HACIENDA DR.
DUBLIN, CA 94568 US
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Contact
JUDITH A BRIMACOMBE
Other 510(k) Applications for this Contact
Regulation Number
886.1570
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Classification Product Code
HLI
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More FDA Info for this Product Code
Date Received
07/01/2005
Decision Date
09/30/2005
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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