The following data is part of a premarket notification filed by Medpro Technologies, Inc. with the FDA for Vacuflow+ Blood Collection Set, Model 52221/3/5; Vacuflow+ With Holder Blood Collection Set, Model 82021/3/5 With Holder.
| Device ID | K000369 |
| 510k Number | K000369 |
| Device Name: | VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDER |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MEDPRO TECHNOLOGIES, INC. 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Contact | Art Ward |
| Correspondent | Art Ward MEDPRO 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 | 2000-02-04 |
| Decision Date | 2000-03-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850011007211 | K000369 | 000 |
| 20850011007208 | K000369 | 000 |
| 00850011007198 | K000369 | 000 |
| 10812460027896 | K000369 | 000 |