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FDA 510(k) Application Details - K183619
Device Classification Name
Prosthesis, Penile
More FDA Info for this Device
510(K) Number
K183619
Device Name
Prosthesis, Penile
Applicant
Boston Scientific Corporation
10700 Bren Road West
Minnetonka, MN 55343 US
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Contact
Laura Kelly
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Regulation Number
876.3630
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Classification Product Code
FAE
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More FDA Info for this Product Code
Date Received
12/26/2018
Decision Date
04/16/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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