The following data is part of a premarket notification filed by Concord/portex with the FDA for Steri-cath Mdi.
| Device ID | K923559 |
| 510k Number | K923559 |
| Device Name: | STERI-CATH MDI |
| Classification | Nebulizer (direct Patient Interface) |
| 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 | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-17 |
| Decision Date | 1993-10-25 |