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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 K862539
Device Name SILICONE DOUBLE COIL URETERAL STENT WITH SUTURE
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 Number876.4620
Classification Product Code
FAD  
Date Received07/02/1986
Decision Date 09/09/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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