The following data is part of a premarket notification filed by Greiner Bio-one Vacuette North America with the FDA for Vacuette Quickshield Safety Tube Holder.
| Device ID | K033478 |
| 510k Number | K033478 |
| Device Name: | VACUETTE QUICKSHIELD SAFETY TUBE HOLDER |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | GREINER BIO-ONE VACUETTE NORTH AMERICA PO BOX 103 Baldwin, MD 21013 |
| Contact | Judi Smith |
| Correspondent | Judi Smith GREINER BIO-ONE VACUETTE NORTH AMERICA PO BOX 103 Baldwin, MD 21013 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-03 |
| Decision Date | 2003-12-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 39120017570982 | K033478 | 000 |