Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K013144 |
Device Name |
DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE; DUAL PORT WIZARD FEEDING/DECOMPRESSION TUBE, MODEL 00220W |
Applicant |
C.R. BARD, INC. |
129 CONCORD RD., BLDG. #3 |
BILLERICA,
MA
01821
|
|
Applicant Contact |
MARION GORDON |
Correspondent |
C.R. BARD, INC. |
129 CONCORD RD., BLDG. #3 |
BILLERICA,
MA
01821
|
|
Correspondent Contact |
MARION GORDON |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 09/20/2001 |
Decision Date | 10/19/2001 |
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
|
|
|