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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 K896198
Device Name MAINSTER WIDE FIELD LASER LENS
Applicant
OCULAR INSTRUMENTS, INC.
2255 116TH AVE., N.E.
BELLEVUE,  WA  98004 -3039
Applicant Contact TAMSIN J ERICKSON
Correspondent
OCULAR INSTRUMENTS, INC.
2255 116TH AVE., N.E.
BELLEVUE,  WA  98004 -3039
Correspondent Contact TAMSIN J ERICKSON
Regulation Number886.1385
Classification Product Code
HJK  
Date Received10/27/1989
Decision Date 12/18/1989
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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