The following data is part of a premarket notification filed by Greiner Vacuette North America, Inc. with the FDA for Vacuette Safety Blood Collection Set.
| Device ID | K011786 |
| 510k Number | K011786 |
| Device Name: | VACUETTE SAFETY BLOOD COLLECTION SET |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | GREINER VACUETTE NORTH AMERICA, INC. P.O. BOX 103 Baldwin, MD 21013 |
| Contact | Judi Smith |
| Correspondent | Judi Smith GREINER VACUETTE 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 | 2001-06-08 |
| Decision Date | 2001-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 39120049202417 | K011786 | 000 |
| 29120126130421 | K011786 | 000 |
| 29120049209983 | K011786 | 000 |
| 39120049209973 | K011786 | 000 |
| 39120049208808 | K011786 | 000 |
| 29120049208795 | K011786 | 000 |
| 29120049208788 | K011786 | 000 |
| 29120049208771 | K011786 | 000 |
| 39120049208761 | K011786 | 000 |
| 39120049208754 | K011786 | 000 |
| 29120049208740 | K011786 | 000 |
| 29120049208726 | K011786 | 000 |
| 29120049208719 | K011786 | 000 |
| 29120017570237 | K011786 | 000 |
| 39120017570241 | K011786 | 000 |
| 39120017570258 | K011786 | 000 |
| 29120049202403 | K011786 | 000 |
| 39120017577684 | K011786 | 000 |
| 39120017577677 | K011786 | 000 |
| 29120017577663 | K011786 | 000 |
| 29120017570350 | K011786 | 000 |
| 29120017570343 | K011786 | 000 |
| 29120017570336 | K011786 | 000 |
| 39120017570326 | K011786 | 000 |
| 29120017570312 | K011786 | 000 |
| 29120017570282 | K011786 | 000 |
| 39120017570272 | K011786 | 000 |
| 39120017570265 | K011786 | 000 |
| 29120049209952 | K011786 | 000 |