The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Stopcock & Luer Lock Plug.
| Device ID | K954970 |
| 510k Number | K954970 |
| Device Name: | STOPCOCK & LUER LOCK PLUG |
| Classification | Stopcock, I.v. Set |
| Applicant | MEDEX, INC. 6250 SHIER RINGS RD. Dublin, OH 40316 |
| Contact | John C Toomey |
| Correspondent | John C Toomey MEDEX, INC. 6250 SHIER RINGS RD. Dublin, OH 40316 |
| Product Code | FMG |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-30 |
| Decision Date | 1996-04-22 |
| Summary: | summary |