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FDA 510(k) Application Details - K042885
Device Classification Name
Ophthalmoscope, Ac-Powered
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510(K) Number
K042885
Device Name
Ophthalmoscope, Ac-Powered
Applicant
OPHTHALMIC TECHNOLOGIES, INC.
377 RT 17 S
HASBROUCK HEIGHTS, NJ 07604 US
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Contact
GEORGE MYERS
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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
10/19/2004
Decision Date
01/21/2005
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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