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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Urethral
510(k) Number K840746
Device Name URETERAL DILATOR
Applicant
American Edwards Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
American Edwards Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5520
Classification Product Code
KOE  
Date Received01/19/1984
Decision Date 04/13/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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