| Device Classification Name |
Connector, Tubing, Dialysate
|
| 510(k) Number |
K862722 |
| Device Name |
TUBING CONNECTOR #10-810-60 100/PKG NON-STERILE |
| Applicant |
| Mercury Enterprises, Inc. |
| 4645 - 145th Ave. N. |
|
Clearwater,
FL
33520
|
|
| Applicant Contact |
GEORGE HOWE |
| Correspondent |
| Mercury Enterprises, Inc. |
| 4645 - 145th Ave. N. |
|
Clearwater,
FL
33520
|
|
| Correspondent Contact |
GEORGE HOWE |
| Regulation Number | 876.5820 |
| Classification Product Code |
|
| Date Received | 07/17/1986 |
| Decision Date | 08/11/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Gastroenterology/Urology
|
| 510k Review Panel |
Gastroenterology/Urology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|