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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ligator, Esophageal
510(k) Number K022434
Device Name BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
Applicant
C.R. Bard, Inc.
129 Concord Rd.
Bldg. #3
Billerica,  MA  01821
Applicant Contact BETH A ZIS
Correspondent
N.V. Kema
P.O. Box 9035
6800 Et Arnhem
Arnhem,  NL
Correspondent Contact PETER N RUYS
Regulation Number876.4400
Classification Product Code
MND  
Date Received07/25/2002
Decision Date 08/05/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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