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 Number | 876.5980
|
Classification Product Code |
|
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
|
|
|