The following data is part of a premarket notification filed by Greiner Vacuette North America, Inc. with the FDA for Vacuette With Ppack.
| Device ID | K002777 |
| 510k Number | K002777 |
| Device Name: | VACUETTE WITH PPACK |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | GREINER VACUETTE NORTH AMERICA, INC. P.O. BOX 6581 Ellicott City, MD 21042 -0581 |
| Contact | Judi Smith |
| Correspondent | Judi Smith GREINER VACUETTE NORTH AMERICA, INC. P.O. BOX 6581 Ellicott City, MD 21042 -0581 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-06 |
| Decision Date | 2000-10-05 |