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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
510(k) Number K921414
Device Name TROKEL /3 GONIO LASER LENS
Applicant
Ocular Instruments, Inc.
2255 116th Ave., NE
Bellevue,  WA  98004 -3039
Applicant Contact TAMSIN J ERICKSON
Correspondent
Ocular Instruments, Inc.
2255 116th Ave., NE
Bellevue,  WA  98004 -3039
Correspondent Contact TAMSIN J ERICKSON
Regulation Number886.4390
Classification Product Code
LQJ  
Date Received03/24/1992
Decision Date 11/16/1992
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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