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 |