FDA 510(k) Application Details - K023816

Device Classification Name Tonometer, Ac-Powered

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510(K) Number K023816
Device Name Tonometer, Ac-Powered
Applicant CANON, INC.-UTSUNOMIYA OPTICAL PRODUCTS OPERATION
ONE CANON PLAZA
LAKE SUCCESS, NY 11042-1198 US
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Contact SHEILA DRISCOLL
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Regulation Number 886.1930

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Classification Product Code HKX
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Date Received 11/15/2002
Decision Date 11/26/2002
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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