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FDA 510(k) Application Details - K073508
Device Classification Name
Device,Analysis,Anterior Segment
More FDA Info for this Device
510(K) Number
K073508
Device Name
Device,Analysis,Anterior Segment
Applicant
OCULUS OPTIKGERATE GMBH
MUNCHHOLZHAUSER STR. 29
WETZLAR D-35582 DE
Other 510(k) Applications for this Company
Contact
JOERG IWANCZUK
Other 510(k) Applications for this Contact
Regulation Number
886.1850
More FDA Info for this Regulation Number
Classification Product Code
MXK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/13/2007
Decision Date
09/11/2008
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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