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FDA 510(k) Application Details - K980357
Device Classification Name
Camera, Ophthalmic, Ac-Powered
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510(K) Number
K980357
Device Name
Camera, Ophthalmic, Ac-Powered
Applicant
KONAN, INC.
377 ROUTE 17 SOUTH
HASBROUCK HEIGHTS, NJ 07604 US
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Contact
GEORGE H MYERS
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Regulation Number
886.1120
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Classification Product Code
HKI
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More FDA Info for this Product Code
Date Received
01/29/1998
Decision Date
04/24/1998
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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