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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 K861088
Device Name BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS
Applicant
Bivona Medical Technologies
5700 W. 23rd Ave.
Gary,  IN  46406
Applicant Contact SHAPIRO, M.D.
Correspondent
Bivona Medical Technologies
5700 W. 23rd Ave.
Gary,  IN  46406
Correspondent Contact SHAPIRO, M.D.
Regulation Number874.3730
Classification Product Code
EWL  
Date Received03/21/1986
Decision Date 04/02/1986
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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