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FDA 510(k) Application Details - K003376
Device Classification Name
Ophthalmoscope, Ac-Powered
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510(K) Number
K003376
Device Name
Ophthalmoscope, Ac-Powered
Applicant
WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS, NY 13153-0220 US
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COLIN WOLFF
Other 510(k) Applications for this Contact
Regulation Number
886.1570
More FDA Info for this Regulation Number
Classification Product Code
HLI
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More FDA Info for this Product Code
Date Received
10/30/2000
Decision Date
01/25/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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