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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 K821568
Device Name BLOW-SINGER TRACHEOSTOMA VALVE
Applicant
BIVONA MEDICAL TECHNOLOGIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BIVONA MEDICAL TECHNOLOGIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.3730
Classification Product Code
EWL  
Date Received05/27/1982
Decision Date 07/26/1982
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
Recalls CDRH Recalls
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