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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 K852793
Device Name URETERAL DILATOR/SHEATH SET
Applicant
AMERICAN EDWARDS LABORATORIES
P.O. BOX 11150
17221 RED HILL AVE.(IRVINE)
SANTA ANA,  CA  92711 -1150
Applicant Contact STEVE SOSNOWSKI
Correspondent
AMERICAN EDWARDS LABORATORIES
P.O. BOX 11150
17221 RED HILL AVE.(IRVINE)
SANTA ANA,  CA  92711 -1150
Correspondent Contact STEVE SOSNOWSKI
Regulation Number876.5470
Classification Product Code
EZN  
Date Received07/01/1985
Decision Date 08/09/1985
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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