The following data is part of a premarket notification filed by Southmedic, Inc. with the FDA for Aerosol-t.
| Device ID | K863318 |
| 510k Number | K863318 |
| Device Name: | AEROSOL-T |
| Classification | Connector, Airway (extension) |
| Applicant | SOUTHMEDIC, INC. P.O. BOX 1365 Barrie, Ontario Canada, CA L4m 5r4 |
| Contact | Lee Mcdonald |
| Correspondent | Lee Mcdonald SOUTHMEDIC, INC. P.O. BOX 1365 Barrie, Ontario Canada, CA L4m 5r4 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-26 |
| Decision Date | 1986-09-11 |