The following data is part of a premarket notification filed by Fvtnks with the FDA for Double Trach Seivel Connector.
| Device ID | K940544 |
| 510k Number | K940544 |
| Device Name: | DOUBLE TRACH SEIVEL CONNECTOR |
| Classification | Connector, Airway (extension) |
| Applicant | FVTNKS 10415 BRIGGS CT. Indianapolis, IN 46256 -9719 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden FVTNKS 10415 BRIGGS CT. Indianapolis, IN 46256 -9719 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-07 |
| Decision Date | 1994-04-19 |