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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 K843280
Device Name MALLEABLE PENILE PROSTHESIS
Applicant
MENTOR CORP.
600 PINE AVE.
GOLETA,  CA  93117
Applicant Contact CHRISTINE EMANUEL
Correspondent
MENTOR CORP.
600 PINE AVE.
GOLETA,  CA  93117
Correspondent Contact CHRISTINE EMANUEL
Regulation Number876.3630
Classification Product Code
FAE  
Date Received08/20/1984
Decision Date 10/24/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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