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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 K842896
Device Name BLOM-SINGER LOW PRESSURE VOICE PROSTHES
Applicant
AMERICAN V. MUELLER
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
AMERICAN V. MUELLER
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number874.3730
Classification Product Code
EWL  
Date Received07/23/1984
Decision Date 08/17/1984
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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