The following data is part of a premarket notification filed by Concord/portex with the FDA for Epidural Minipack.
| Device ID | K924541 |
| 510k Number | K924541 |
| Device Name: | EPIDURAL MINIPACK |
| Classification | Bottle, Blow |
| Applicant | CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
| Contact | Robert Wheeler |
| Correspondent | Robert Wheeler CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
| Product Code | BYO |
| CFR Regulation Number | 868.5220 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-08 |
| Decision Date | 1993-07-09 |