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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chair, Ophthalmic, Ac-Powered
510(k) Number K853743
Device Name TECHNA VISION, INC. ELECTRIC CHAIR
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 Number886.1140
Classification Product Code
HME  
Date Received09/06/1985
Decision Date 10/17/1985
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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