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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Activation, Breath Control
510(k) Number K964977
Device Name IVOC- INTEGRATED VOICE OPERATED CONTROL UNIT (IVOC-1)
Applicant
Interactive Living Systems, Inc.
14901 E. Hampden Ave.,
Suite 310
Aurora,  CO  80014
Applicant Contact ORVILLE K HOLLENBECK
Correspondent
Interactive Living Systems, Inc.
14901 E. Hampden Ave.,
Suite 310
Aurora,  CO  80014
Correspondent Contact ORVILLE K HOLLENBECK
Regulation Number890.3920
Classification Product Code
LFF  
Date Received12/12/1996
Decision Date 08/31/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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