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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 K853940
Device Name THE GRONINGEN VOICE PROSTHESIS
Applicant
Hood Laboratories
575 Washington St.
Pembroke,  MA  02359
Applicant Contact BRUCE BARBER
Correspondent
Hood Laboratories
575 Washington St.
Pembroke,  MA  02359
Correspondent Contact BRUCE BARBER
Regulation Number874.3730
Classification Product Code
EWL  
Date Received09/24/1985
Decision Date 12/13/1985
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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