The following data is part of a premarket notification filed by Mediflex Intl. with the FDA for Blood Tubing Set.
| Device ID | K884243 |
| 510k Number | K884243 |
| Device Name: | BLOOD TUBING SET |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | MEDIFLEX INTL. 45 KULICK RD. Fairfield, NJ 07006 |
| Contact | Udine |
| Correspondent | Udine MEDIFLEX INTL. 45 KULICK RD. Fairfield, NJ 07006 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-11 |
| Decision Date | 1988-12-08 |