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FDA 510(k) Application Details - K990205
Device Classification Name
Camera, Ophthalmic, Ac-Powered
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510(K) Number
K990205
Device Name
Camera, Ophthalmic, Ac-Powered
Applicant
EYE TEL IMAGING, INC.
15078 STILLFIELD PLACE
CENTREVILLE, VA 20120 US
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Contact
KEVIN T QUINN
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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
01/21/1999
Decision Date
03/26/1999
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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