The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Hollow Lumen Needle, Part Number: Mx920.
| Device ID | K903199 |
| 510k Number | K903199 |
| Device Name: | HOLLOW LUMEN NEEDLE, PART NUMBER: MX920 |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | MEDEX, INC. 6250 SHIER RINGS RD. Dublin, OH 40316 |
| Contact | Cathy Chenetski |
| Correspondent | Cathy Chenetski MEDEX, INC. 6250 SHIER RINGS RD. Dublin, OH 40316 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-20 |
| Decision Date | 1990-12-17 |