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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 K905576
Device Name LINGRAPHICA VISUAL LANGUAGE PROSTHESIS
Applicant
Tolfa Corp.
1963 Rock St.
Suite #17
Mountain View,  CA  94043
Applicant Contact CHARLES L ROSE
Correspondent
Tolfa Corp.
1963 Rock St.
Suite #17
Mountain View,  CA  94043
Correspondent Contact CHARLES L ROSE
Regulation Number890.3710
Classification Product Code
ILQ  
Date Received12/12/1990
Decision Date 12/31/1990
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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