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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Esophageal
510(k) Number K033936
Device Name BARD ELIMINATOR PET BALLOON DILATORS
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 Number876.5365
Classification Product Code
KNQ  
Date Received12/19/2003
Decision Date 01/14/2004
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
Recalls CDRH Recalls
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