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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Lens, Trial, Ophthalmic
510(k) Number K930195
Device Name OPHTHALMIC TRIAL LENSES
Applicant
Optimark Accessories and Instruments
P.O. Box 14115
Seattle,  WA  98104
Applicant Contact CHRISTINE K MARK
Correspondent
Optimark Accessories and Instruments
P.O. Box 14115
Seattle,  WA  98104
Correspondent Contact CHRISTINE K MARK
Regulation Number886.1405
Classification Product Code
HPC  
Date Received01/14/1993
Decision Date 01/06/1994
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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