The following data is part of a premarket notification filed by Greiner Meditech, Inc. with the FDA for Vacuette Multiple Sample Luer Adapter.
| Device ID | K981619 |
| 510k Number | K981619 |
| Device Name: | VACUETTE MULTIPLE SAMPLE LUER ADAPTER |
| 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 | 1998-05-06 |
| Decision Date | 1998-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 39120017570173 | K981619 | 000 |