The following data is part of a premarket notification filed by Med-pro Technologies, Inc. with the FDA for Vacuflow+safe Blood Collection Set And Vacuflow+safe With Holder Blood Collection Set.
| Device ID | K000714 |
| 510k Number | K000714 |
| Device Name: | VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SET |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MED-PRO TECHNOLOGIES, INC. 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Contact | Art Ward |
| Correspondent | Art Ward MED-PRO TECHNOLOGIES, INC. 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-02 |
| Decision Date | 2000-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850011007181 | K000714 | 000 |
| 20850011007055 | K000714 | 000 |
| 00850011007006 | K000714 | 000 |
| 10812460027872 | K000714 | 000 |