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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Catheter, Ureteral
510(k) Number K850355
Device Name MENTOR PERCUTANEOUS RENAL DILATOR SET
Applicant
Mentor Corp.
600 Pine Ave.
Goleta,  CA  93117
Applicant Contact GREGORY L JOHNSON
Correspondent
Mentor Corp.
600 Pine Ave.
Goleta,  CA  93117
Correspondent Contact GREGORY L JOHNSON
Regulation Number876.5470
Classification Product Code
EZN  
Date Received01/30/1985
Decision Date 03/12/1985
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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