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FDA 510(k) Application Details - K030719
Device Classification Name
Device,Analysis,Anterior Segment
More FDA Info for this Device
510(K) Number
K030719
Device Name
Device,Analysis,Anterior Segment
Applicant
OCULUS OPTIKGERATE GMBH
18902 NE 150TH ST.
WOODINVILLE, WA 98072 US
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Contact
TOM WEATHERBY
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Regulation Number
886.1850
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Classification Product Code
MXK
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More FDA Info for this Product Code
Date Received
03/07/2003
Decision Date
09/16/2003
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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