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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Environmental Control, Powered
510(k) Number K911101
Device Name TONGUETOUCH KEYPAD AND ZOFCOM CONTROL SYSTEM
Applicant
ZOFCOM, INC.
3962 NELSON COURT
PALO ALTO,  CA  94306
Applicant Contact RIC BARLINE
Correspondent
ZOFCOM, INC.
3962 NELSON COURT
PALO ALTO,  CA  94306
Correspondent Contact RIC BARLINE
Regulation Number890.3725
Classification Product Code
IQA  
Date Received03/13/1991
Decision Date 04/25/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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