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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Penile
510(k) Number K183619
Device Name Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device
Applicant
Boston Scientific Corporation
10700 Bren Road West
Minnetonka,  MN  55343
Applicant Contact Laura Kelly
Correspondent
Boston Scientific Corporation
10700 Bren Road West
Minnetonka,  MN  55343
Correspondent Contact Laura Kelly
Regulation Number876.3630
Classification Product Code
FAE  
Date Received12/26/2018
Decision Date 04/16/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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