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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 K900371
Device Name MENTOR MODIFIED MALLEABLE PENILE PROSTHESES
Applicant
MENTOR CORP.
600 PINE AVE.
GOLETA,  CA  93117
Applicant Contact TERRY A THOMPSON
Correspondent
MENTOR CORP.
600 PINE AVE.
GOLETA,  CA  93117
Correspondent Contact TERRY A THOMPSON
Regulation Number876.3630
Classification Product Code
FAE  
Date Received01/26/1990
Decision Date 11/02/1990
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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