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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stent, ureteral
510(k) Number K912060
Device Name MENTOR BLACK LIGHT INJECTION STENT SET
Applicant
MENTOR CORP.
600 PINE AVE.
GOLETA,  CA  93117
Applicant Contact BYRON H.WICKETT
Correspondent
MENTOR CORP.
600 PINE AVE.
GOLETA,  CA  93117
Correspondent Contact BYRON H.WICKETT
Regulation Number876.4620
Classification Product Code
FAD  
Date Received05/09/1991
Decision Date 09/27/1991
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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