Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K924850 |
Device Name |
VANSONNENBERG GASTROSTOMY CATHETER |
Applicant |
BOSTON SCIENTIFIC CORP. |
2710 ORCHARD PKWY. |
SAN JOSE,
CA
95134
|
|
Applicant Contact |
PAMELA L CADORETTE |
Correspondent |
BOSTON SCIENTIFIC CORP. |
2710 ORCHARD PKWY. |
SAN JOSE,
CA
95134
|
|
Correspondent Contact |
PAMELA L CADORETTE |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 09/28/1992 |
Decision Date | 12/29/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|