The following data is part of a premarket notification filed by Medipart Jerry Alexander with the FDA for Mp-01x Disposable Bacteria Filter Kit.
| Device ID | K862789 |
| 510k Number | K862789 |
| Device Name: | MP-01X DISPOSABLE BACTERIA FILTER KIT |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | MEDIPART JERRY ALEXANDER 607 SPRING BEACH RD. Cary, IL 60013 |
| Contact | Jerry Alexander |
| Correspondent | Jerry Alexander MEDIPART JERRY ALEXANDER 607 SPRING BEACH RD. Cary, IL 60013 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-23 |
| Decision Date | 1986-08-01 |