The following data is part of a premarket notification filed by Greiner Meditech, Inc. with the FDA for Vacuette (multi-use Holder).
| Device ID | K974873 |
| 510k Number | K974873 |
| Device Name: | VACUETTE (MULTI-USE HOLDER) |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| 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 | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-29 |
| Decision Date | 1998-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 39120017577479 | K974873 | 000 |