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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 K870695
Device Name VAN-TEC URETHRAL DILATATION SYSTEM
Applicant
Van-Tec, Inc.
P.O. Box 26
Spencer,  IN  47460
Applicant Contact JAMES F VANCE
Correspondent
Van-Tec, Inc.
P.O. Box 26
Spencer,  IN  47460
Correspondent Contact JAMES F VANCE
Regulation Number876.5520
Classification Product Code
KOE  
Date Received02/19/1987
Decision Date 03/10/1987
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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