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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 K951437
Device Name OTI MODEL TLS-60
Applicant
Oti Medical, LLC
530 Bercut Dr.
Suiter J
Sacramento,  CA  95814
Applicant Contact WILL MARKLE
Correspondent
Oti Medical, LLC
530 Bercut Dr.
Suiter J
Sacramento,  CA  95814
Correspondent Contact WILL MARKLE
Regulation Number886.1405
Classification Product Code
HPC  
Date Received03/27/1995
Decision Date 04/11/1995
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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