The following data is part of a premarket notification filed by Seven Harvest Intl. Import & Export with the FDA for Double Trach Swivel Connector.
| Device ID | K940793 |
| 510k Number | K940793 |
| Device Name: | DOUBLE TRACH SWIVEL CONNECTOR |
| Classification | Connector, Airway (extension) |
| Applicant | SEVEN HARVEST INTL. IMPORT & EXPORT P.O. BOX 395 Tipton, IN 46072 |
| Contact | Charles K Mountbatten-windsor |
| Correspondent | Charles K Mountbatten-windsor SEVEN HARVEST INTL. IMPORT & EXPORT P.O. BOX 395 Tipton, IN 46072 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-22 |
| Decision Date | 1994-07-01 |