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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Evacuator, Gastro-Urology
510(k) Number K880099
Device Name VAN-TEC BLADDER EVACUATOR
Applicant
VAN-TEC, INC.
P.O. BOX 26
SPENCER,  IN  47460
Applicant Contact VANCE, JR.
Correspondent
VAN-TEC, INC.
P.O. BOX 26
SPENCER,  IN  47460
Correspondent Contact VANCE, JR.
Regulation Number876.4370
Classification Product Code
KQT  
Date Received01/12/1988
Decision Date 03/02/1988
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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