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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Laryngeal (Taub)
510(k) Number K974132
Device Name VOICE MASTER PROSTHESIS
Applicant
E. Benson Hood Lab, Inc.
575 Washington St.
Pembroke,  MA  02359
Applicant Contact ANTHONY M SACCHETTI
Correspondent
E. Benson Hood Lab, Inc.
575 Washington St.
Pembroke,  MA  02359
Correspondent Contact ANTHONY M SACCHETTI
Regulation Number874.3730
Classification Product Code
EWL  
Date Received11/03/1997
Decision Date 02/25/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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