The following data is part of a premarket notification filed by Medipart Jerry Alexander with the FDA for Medipart Disposable Aerosol System Mp-070-ptd.
| Device ID | K894138 |
| 510k Number | K894138 |
| Device Name: | MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MEDIPART JERRY ALEXANDER 607 SPRING BEACH RD. Cary, IL 60013 |
| Contact | Jery Alexander |
| Correspondent | Jery Alexander MEDIPART JERRY ALEXANDER 607 SPRING BEACH RD. Cary, IL 60013 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-13 |
| Decision Date | 1989-09-26 |