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FDA 510(k) Application Details - K063310
Device Classification Name
Perimeter, Automatic, Ac-Powered
More FDA Info for this Device
510(K) Number
K063310
Device Name
Perimeter, Automatic, Ac-Powered
Applicant
SEEING MACHINES LIMITED
11440 WEST BERNARDO CT.
SUITE 300
SAN DIEGO, CA 92127-1644 US
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Contact
ALAN DONALD
Other 510(k) Applications for this Contact
Regulation Number
886.1605
More FDA Info for this Regulation Number
Classification Product Code
HPT
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More FDA Info for this Product Code
Date Received
11/02/2006
Decision Date
08/02/2007
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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