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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Spectacle, Non-Custom (Prescription)
510(k) Number K862578
Device Name TECHNA VISION CASTING RESIN
Applicant
Techna Vision
11489 Woodside Ave.
Santee,  CA  92071
Applicant Contact JAMES T KELLEY
Correspondent
Techna Vision
11489 Woodside Ave.
Santee,  CA  92071
Correspondent Contact JAMES T KELLEY
Regulation Number886.5844
Classification Product Code
HQG  
Date Received07/07/1986
Decision Date 07/23/1986
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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