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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 K933976
Device Name MANDELKORN SUTURE LYSIS 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 Received08/13/1993
Decision Date 11/08/1994
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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