FDA 510(k) Application Details - K063717

Device Classification Name Camera, Ophthalmic, Ac-Powered

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510(K) Number K063717
Device Name Camera, Ophthalmic, Ac-Powered
Applicant CANON, INC.
ONE CANON PLAZA
LAKE SUCCESS, NY 11042-1198 US
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Contact SHEILA DRISCOLL
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Regulation Number 886.1120

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Classification Product Code HKI
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Date Received 12/14/2006
Decision Date 01/23/2007
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 Y
Expedited Review



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