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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spermatocele, Alloplastic
510(k) Number K863565
Device Name MENTOR ALLOPLASTIC SPERMATOCELE
Applicant
Mentor Corp.
600 Pine Ave.
Goleta,  CA  93117
Applicant Contact BYRON WICKETT
Correspondent
Mentor Corp.
600 Pine Ave.
Goleta,  CA  93117
Correspondent Contact BYRON WICKETT
Classification Product Code
LQS  
Date Received09/12/1986
Decision Date 11/19/1986
Decision Substantially Equivalent (SESE)
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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