FDA 510(k) Application Details - K014170

Device Classification Name Lens, Contact, Polymethylmethacrylate, Diagnostic

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510(K) Number K014170
Device Name Lens, Contact, Polymethylmethacrylate, Diagnostic
Applicant OCULAR INSTRUMENTS, INC.
2255 116TH AVE., N.E.
BELLEVUE, WA 98004-3039 US
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Contact RAYMOND GRAHAM
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Regulation Number 886.1385

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Classification Product Code HJK
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Date Received 12/20/2001
Decision Date 03/04/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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