The following data is part of a premarket notification filed by Greiner Bio-one North America, Inc. with the FDA for Vacuette Quickshield With Snappy Tube Holder.
| Device ID | K113505 |
| 510k Number | K113505 |
| Device Name: | VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | GREINER BIO-ONE NORTH AMERICA, INC. P.O. BOX 103 Baldwin, MD 21013 |
| Contact | Judi Smith |
| Correspondent | Judi Smith GREINER BIO-ONE NORTH AMERICA, INC. P.O. 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 | 2011-11-28 |
| Decision Date | 2012-02-17 |
| Summary: | summary |