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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact, Polymethylmethacrylate, Diagnostic
510(k) Number K014170
Device Name STAURENGHI WIDE FIELD SCANNING LASER LENS
Applicant
Ocular Instruments, Inc.
2255 116th Ave., NE
Bellevue,  WA  98004 -3039
Applicant Contact RAYMOND GRAHAM
Correspondent
Ocular Instruments, Inc.
2255 116th Ave., NE
Bellevue,  WA  98004 -3039
Correspondent Contact RAYMOND GRAHAM
Regulation Number886.1385
Classification Product Code
HJK  
Date Received12/20/2001
Decision Date 03/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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