FASTRAC GASTRIC ACCESS PORT KIT

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

Correspodent Contact thomas hirte, p.e.
Regulation Number 876.5980
Classification Product Code
KNT  
Date Received 11/12/2003
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