The following data is part of a premarket notification filed by Greiner Meditech, Inc. with the FDA for Vacuette Multi-sample Needle.
| Device ID | K973620 |
| 510k Number | K973620 |
| Device Name: | VACUETTE MULTI-SAMPLE NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | GREINER MEDITECH, INC. 260 GATEWAY DRIVE, SUITE 17A Bel Air, MD 21014 |
| Contact | Douglas L Harris |
| Correspondent | Douglas L Harris GREINER MEDITECH, INC. 260 GATEWAY DRIVE, SUITE 17A Bel Air, MD 21014 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-23 |
| Decision Date | 1997-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 39120049205029 | K973620 | 000 |
| 39120049205012 | K973620 | 000 |
| 49120049205002 | K973620 | 000 |
| 49120017570217 | K973620 | 000 |
| 49120017570200 | K973620 | 000 |
| 39120017570197 | K973620 | 000 |
| 39120017570180 | K973620 | 000 |
| 49120017570019 | K973620 | 000 |
| 39120017570005 | K973620 | 000 |