Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K002838 |
Device Name |
GASTRIC SUCTION AND DRAINAGE CATHETER |
Applicant |
BIOENTERICS CORP. |
1035 CINDY LN. |
CARPINTERIA,
CA
93013
|
|
Applicant Contact |
DAVID MUNJAL |
Correspondent |
BIOENTERICS CORP. |
1035 CINDY LN. |
CARPINTERIA,
CA
93013
|
|
Correspondent Contact |
DAVID MUNJAL |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 09/12/2000 |
Decision Date | 07/09/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|