The following data is part of a premarket notification filed by Greiner Bio-one Vacuette North America with the FDA for Safety Infusion Set.
| Device ID | K080235 |
| 510k Number | K080235 |
| Device Name: | SAFETY INFUSION SET |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | GREINER BIO-ONE VACUETTE NORTH AMERICA 13801 ECK ROAD Hydes, MD 21082 |
| Contact | Judith Smith |
| Correspondent | Judith Smith GREINER BIO-ONE VACUETTE NORTH AMERICA 13801 ECK ROAD Hydes, MD 21082 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-30 |
| Decision Date | 2008-04-24 |
| Summary: | summary |