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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 K934483
Device Name NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX
Applicant
Mountain Precision Mfg. Ltd. Co.
10688 Executive Dr.
P.O. Box 4983
Boise,  ID  83704
Applicant Contact EUGENE J BRESKI
Correspondent
Mountain Precision Mfg. Ltd. Co.
10688 Executive Dr.
P.O. Box 4983
Boise,  ID  83704
Correspondent Contact EUGENE J BRESKI
Regulation Number874.3375
Classification Product Code
ESE  
Date Received09/14/1993
Decision Date 03/16/1994
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
Predetermined Change
Control Plan Authorized		 No
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