The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Miniloop I.v. Connectors & Adaptor.
| Device ID | K830152 |
| 510k Number | K830152 |
| Device Name: | MINILOOP I.V. CONNECTORS & ADAPTOR |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDEX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-18 |
| Decision Date | 1983-02-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50351688507103 | K830152 | 000 |
| 50351688507097 | K830152 | 000 |