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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K855086
Device Name KATALAVOX VOICE-ACTIVATED SWITCHING DEVICE
Applicant
Kempf Co.
655 S. Fair Oaks Ave.
B-303
Sunnyvale,  CA  94086
Applicant Contact MARTINE KEMPF
Correspondent
Kempf Co.
655 S. Fair Oaks Ave.
B-303
Sunnyvale,  CA  94086
Correspondent Contact MARTINE KEMPF
Regulation Number890.3860
Classification Product Code
ITI  
Date Received12/20/1985
Decision Date 04/04/1986
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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