The following data is part of a premarket notification filed by Medipart Jerry Alexander with the FDA for Mp-4400 Mouthpiece-flange Seal.
| Device ID | K862788 |
| 510k Number | K862788 |
| Device Name: | MP-4400 MOUTHPIECE-FLANGE SEAL |
| Classification | Mouthpiece, Breathing |
| 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 | BYP |
| CFR Regulation Number | 868.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-23 |
| Decision Date | 1986-08-01 |