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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 K842639
Device Name AMER. EDWARDS LAB DIAFLEX URETERAL DILA
Applicant
AMERICAN EDWARDS LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMERICAN EDWARDS LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5470
Classification Product Code
EZN  
Date Received07/09/1984
Decision Date 10/02/1984
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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