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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 K860517
Device Name MENTOR CORPORAL DILATORS
Applicant
Mentor Corp.
600 Pine Ave.
Goleta,  CA  93117
Applicant Contact KAREN EDWARDS
Correspondent
Mentor Corp.
600 Pine Ave.
Goleta,  CA  93117
Correspondent Contact KAREN EDWARDS
Regulation Number876.3630
Classification Product Code
FAE  
Date Received02/11/1986
Decision Date 03/11/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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