FDA 510(k) Application Details - K063310

Device Classification Name Perimeter, Automatic, Ac-Powered

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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
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Regulation Number 886.1605

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Classification Product Code HPT
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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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