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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name larynx, artificial (battery-powered)
510(k) Number K860992
Device Name VOX COMPANION
Applicant
BLOOMFIELD RESEARCH AND DEVELOPMENT, INC.
P.O. BOX 23980
HILTON HEAD,  SC  29925
Applicant Contact DAVID LIVELY
Correspondent
BLOOMFIELD RESEARCH AND DEVELOPMENT, INC.
P.O. BOX 23980
HILTON HEAD,  SC  29925
Correspondent Contact DAVID LIVELY
Regulation Number874.3375
Classification Product Code
ESE  
Date Received03/17/1986
Decision Date 05/02/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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