Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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 ROAD
BUILDING 3
BILLERICA,  MA  01821
Applicant Contact THOMAS HIRTE, P.E.
Correspondent
C.R. BARD, INC.
129 CONCORD ROAD
BUILDING 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
Recalls CDRH Recalls
-
-