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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 K933264
Device Name RITCH NYLON SUTURE LASER LENS
Applicant
Ocular Instruments, Inc.
2255 116th Ave., NE
Bellevue,  WA  98004
Applicant Contact TAMSIN J ERICKSON
Correspondent
Ocular Instruments, Inc.
2255 116th Ave., NE
Bellevue,  WA  98004
Correspondent Contact TAMSIN J ERICKSON
Regulation Number886.1385
Classification Product Code
HJK  
Date Received07/06/1993
Decision Date 10/31/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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