The following data is part of a premarket notification filed by Thayer Medical Corp. with the FDA for Thayer Mask To Mouthpiece Adapter/connector.
| Device ID | K941026 |
| 510k Number | K941026 |
| Device Name: | THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR |
| Classification | Connector, Airway (extension) |
| Applicant | THAYER MEDICAL CORP. 4575 SOUTH PALO VERDE RD., SUITE 337 Tucson, AZ 85714 |
| Contact | David Sladek |
| Correspondent | David Sladek THAYER MEDICAL CORP. 4575 SOUTH PALO VERDE RD., SUITE 337 Tucson, AZ 85714 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-04 |
| Decision Date | 1994-08-18 |