The following data is part of a premarket notification filed by Greiner Meditech, Inc. with the FDA for Ecomed Scalp Vein Set.
| Device ID | K992145 |
| 510k Number | K992145 |
| Device Name: | ECOMED SCALP VEIN SET |
| Classification | Set, Administration, Intravascular |
| 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 | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-24 |
| Decision Date | 1999-10-14 |
| Summary: | summary |