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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K033562
Device Name FASTRAC GASTRIC ACCESS PORT KIT
Applicant
C.R. Bard, Inc.
129 Concord Rd.
Bldg. #3
Billerica,  MA  01821
Applicant Contact THOMAS HIRTE, P.E.
Correspondent
C.R. Bard, Inc.
129 Concord Rd.
Bldg. #3
Billerica,  MA  01821
Correspondent Contact THOMAS HIRTE, P.E.
Regulation Number876.5980
Classification Product Code
KNT  
Date Received11/12/2003
Decision Date 12/12/2003
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
Recalls CDRH Recalls
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