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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Communication, Powered
510(k) Number K864204
Device Name VOCAID, ELECTRONIC VOCAL AID
Applicant
Texas Instruments, Inc.
P.O. Box 10508 Mail Station
5818
Lubbock,  TX  79415
Applicant Contact EDWARD J LOHMANN
Correspondent
Texas Instruments, Inc.
P.O. Box 10508 Mail Station
5818
Lubbock,  TX  79415
Correspondent Contact EDWARD J LOHMANN
Regulation Number890.3710
Classification Product Code
ILQ  
Date Received10/27/1986
Decision Date 11/14/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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