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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 K864418
Device Name LANDERS INDIRECT VITRECTOMY LENS
Applicant
OCULAR INSTRUMENTS, INC.
12100 NORTHUP WAY
SUITE D
BELLEVUE,  WA  98005
Applicant Contact TAMSIN J ERICKSON
Correspondent
OCULAR INSTRUMENTS, INC.
12100 NORTHUP WAY
SUITE D
BELLEVUE,  WA  98005
Correspondent Contact TAMSIN J ERICKSON
Regulation Number886.1385
Classification Product Code
HJK  
Date Received11/10/1986
Decision Date 11/28/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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