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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 K842632
Device Name DILATOR/SHEATH SET
Applicant
AMERICAN EDWARDS LABORATORIES
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
AMERICAN EDWARDS LABORATORIES
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5470
Classification Product Code
EZN  
Date Received07/06/1984
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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