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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name marker, ocular
510(k) Number K053475
Device Name OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450
Applicant
REFRACTEC, INC.
5 JENNER, SUITE 150
IRVINE,  CA  92618
Applicant Contact GARY MOCNIK
Correspondent
REFRACTEC, INC.
5 JENNER, SUITE 150
IRVINE,  CA  92618
Correspondent Contact GARY MOCNIK
Regulation Number886.4570
Classification Product Code
HMR  
Subsequent Product Code
HMQ  
Date Received12/14/2005
Decision Date 03/03/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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