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FDA 510(k) Application Details - K964137
Device Classification Name
Ophthalmoscope, Ac-Powered
More FDA Info for this Device
510(K) Number
K964137
Device Name
Ophthalmoscope, Ac-Powered
Applicant
TALIA TECHNOLOGY LTD.
COLUMBIA SQUARE
555 THIRTEENTH STREET N.W.
WASHINGTON, DC 20004-1109 US
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Contact
JONATHAN S KAHAN
Other 510(k) Applications for this Contact
Regulation Number
886.1570
More FDA Info for this Regulation Number
Classification Product Code
HLI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/15/1996
Decision Date
02/03/1997
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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