The following data is part of a premarket notification filed by Unicor, Inc. with the FDA for Unicor, Inc. Connectors & Airway Extensions.
Device ID | K953786 |
510k Number | K953786 |
Device Name: | UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS |
Classification | Connector, Airway (extension) |
Applicant | UNICOR, INC. 1300 25TH ST. SUITE 11 Cleveland, TN 37311 |
Contact | Loretta J Hart |
Correspondent | Loretta J Hart UNICOR, INC. 1300 25TH ST. SUITE 11 Cleveland, TN 37311 |
Product Code | BZA |
CFR Regulation Number | 868.5810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-14 |
Decision Date | 1995-09-19 |