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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Table, Instrument, Powered, Ophthalmic
510(k) Number K853744
Device Name TECHNA VISION, INC.ELECTRIC TABLE
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 Number886.4855
Classification Product Code
HRJ  
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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