The following data is part of a premarket notification filed by Greiner Bio-one Na Inc with the FDA for Vacuette Evoprotect Safety Blood Collection / Infusion Set.
| Device ID | K173757 |
| 510k Number | K173757 |
| Device Name: | VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Greiner Bio-One NA Inc 4238 Capital Drive Monroe, NC 28110 |
| Contact | Manfred Abel |
| Correspondent | Manfred Abel Greiner Bio-One NA Inc 4238 Capital Drive Monroe, NC 28110 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-11 |
| Decision Date | 2018-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 29120049206630 | K173757 | 000 |
| 29120049206616 | K173757 | 000 |
| 39120049207023 | K173757 | 000 |
| 29120049206623 | K173757 | 000 |
| 29120049206593 | K173757 | 000 |
| 39120049206583 | K173757 | 000 |