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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 K811833
Device Name VNACE FASCIAL DILATOR SET
Applicant
VANCE PRODUCTS, INC.
MD 
Correspondent
VANCE PRODUCTS, INC.
MD 
Regulation Number876.5520
Classification Product Code
KOE  
Date Received06/30/1981
Decision Date 07/10/1981
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
Recalls CDRH Recalls
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