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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 K910796
Device Name COMPANION SPEECH AID, MODEL 432
Applicant
Companion Products Intl.
P.O. Box 13133
Coyote,  CA  95013
Applicant Contact ROBERT W LANGSTROTH
Correspondent
Companion Products Intl.
P.O. Box 13133
Coyote,  CA  95013
Correspondent Contact ROBERT W LANGSTROTH
Regulation Number890.3710
Classification Product Code
ILQ  
Date Received02/26/1991
Decision Date 03/07/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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