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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 K832808
Device Name URETERAL DILATION SET
Applicant
Van-Tec, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Van-Tec, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5470
Classification Product Code
EZN  
Date Received08/18/1983
Decision Date 10/14/1983
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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