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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 K040959
Device Name MENTOR GENESIS PENILE PROSTHESIS
Applicant
Mentor Corp.
201 Mentor Dr.
Santa Barbara,  CA  93111
Applicant Contact DONNA A CRAWFORD
Correspondent
Mentor Corp.
201 Mentor Dr.
Santa Barbara,  CA  93111
Correspondent Contact DONNA A CRAWFORD
Regulation Number876.3630
Classification Product Code
FAE  
Date Received04/13/2004
Decision Date 10/29/2004
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
Recalls CDRH Recalls
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