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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 K033245
Device Name BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
Applicant
C.R. BARD, INC.
129 CONCORD RD., BLDG. #3
BILLERICA,  MA  01821
Applicant Contact MICHAEL A PATZ
Correspondent
C.R. BARD, INC.
129 CONCORD RD., BLDG. #3
BILLERICA,  MA  01821
Correspondent Contact MICHAEL A PATZ
Regulation Number876.4400
Classification Product Code
MND  
Date Received10/07/2003
Decision Date 11/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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