The following data is part of a premarket notification filed by Greiner Bio-one North America, Inc. with the FDA for Vacuette Visio Plus Blood Collection Needles.
| Device ID | K061483 |
| 510k Number | K061483 |
| Device Name: | VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES |
| 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 | 2006-05-30 |
| Decision Date | 2006-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 49120017570088 | K061483 | 000 |
| 39120017570074 | K061483 | 000 |
| 39120017570067 | K061483 | 000 |
| 39120017570050 | K061483 | 000 |
| 49120049204999 | K061483 | 000 |
| 39120049204985 | K061483 | 000 |