Device Classification Name |
catheter, peritoneal, long-term indwelling
|
510(k) Number |
K930175 |
Device Name |
CATH BELT PD CATHETER AND TRANSFER SET HOLDER |
Applicant |
TABEX INDUSTRIES, INC. |
5050 POPLAR AV. |
SUITE 732 |
MEMPHIS,
TN
38157
|
|
Applicant Contact |
PHILIP W FENTRESS |
Correspondent |
TABEX INDUSTRIES, INC. |
5050 POPLAR AV. |
SUITE 732 |
MEMPHIS,
TN
38157
|
|
Correspondent Contact |
PHILIP W FENTRESS |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 01/13/1993 |
Decision Date | 06/23/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|