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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 K915761
Device Name BIVONA-COLORADO VOICE PROSTHESIS
Applicant
BIVONA MEDICAL TECHNOLOGIES
5700 WEST 23RD AVE.
GARY,  IN  46406
Applicant Contact HARRY KAUFMAN
Correspondent
BIVONA MEDICAL TECHNOLOGIES
5700 WEST 23RD AVE.
GARY,  IN  46406
Correspondent Contact HARRY KAUFMAN
Regulation Number874.3730
Classification Product Code
EWL  
Date Received12/24/1991
Decision Date 06/29/1992
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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