The following data is part of a premarket notification filed by Medicomp, Inc. with the FDA for Medicomp Inhalant Mask Elbow.
| Device ID | K864896 |
| 510k Number | K864896 |
| Device Name: | MEDICOMP INHALANT MASK ELBOW |
| Classification | Connector, Airway (extension) |
| Applicant | MEDICOMP, INC. ROUTE 3 Princeton, MN 55371 |
| Contact | Duncan G Johnson |
| Correspondent | Duncan G Johnson MEDICOMP, INC. ROUTE 3 Princeton, MN 55371 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-15 |
| Decision Date | 1987-02-20 |