The following data is part of a premarket notification filed by Med-west, Inc. with the FDA for Mni 400 Injection Caps.
| Device ID | K852162 |
| 510k Number | K852162 |
| Device Name: | MNI 400 INJECTION CAPS |
| Classification | Catheter, Subclavian |
| Applicant | MED-WEST, INC. 2203 ALEXANDER Salt Lake City, UT 84119 |
| Contact | David Beattie |
| Correspondent | David Beattie MED-WEST, INC. 2203 ALEXANDER Salt Lake City, UT 84119 |
| Product Code | LFJ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-20 |
| Decision Date | 1985-06-12 |