The following data is part of a premarket notification filed by Medflex International, Inc. with the FDA for Blood Tubing Set.
| Device ID | K852605 |
| 510k Number | K852605 |
| Device Name: | BLOOD TUBING SET |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | MEDFLEX INTERNATIONAL, INC. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Contact | Edgar Udine |
| Correspondent | Edgar Udine MEDFLEX INTERNATIONAL, INC. 1129 BLOOMFIELD AVE. West Caldwell, 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 | 1985-06-19 |
| Decision Date | 1985-07-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20858293006025 | K852605 | 000 |
| 20858293006001 | K852605 | 000 |
| 08053323800019 | K852605 | 000 |