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FDA 510(k) Application Details - K041290
Device Classification Name
Ophthalmoscope, Ac-Powered
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510(K) Number
K041290
Device Name
Ophthalmoscope, Ac-Powered
Applicant
TALIA TECHNOLOGY LTD.
555 THIRTEENTH ST. 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
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Classification Product Code
HLI
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More FDA Info for this Product Code
Date Received
05/13/2004
Decision Date
05/24/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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