The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Airway Connector With Flex Tube.
| Device ID | K942392 |
| 510k Number | K942392 |
| Device Name: | AIRWAY CONNECTOR WITH FLEX TUBE |
| Classification | Connector, Airway (extension) |
| Applicant | MALLINCKRODT MEDICAL R.D. #1 BOX 1173 HOOK ROAD Argyle, NY 12809 |
| Contact | James C Webber |
| Correspondent | James C Webber MALLINCKRODT MEDICAL R.D. #1 BOX 1173 HOOK ROAD Argyle, NY 12809 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-19 |
| Decision Date | 1994-08-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884522024624 | K942392 | 000 |
| 20884522039311 | K942392 | 000 |
| 20884522032756 | K942392 | 000 |
| 20884522032749 | K942392 | 000 |