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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 K832852
Device Name BLAISE-RATHAEL VOICE PROSTHESIS
Applicant
RICHARDS MEDICAL CO., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
RICHARDS MEDICAL CO., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number874.3730
Classification Product Code
EWL  
Date Received08/16/1983
Decision Date 09/29/1983
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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