The following data is part of a premarket notification filed by Intertex Medical, Inc. with the FDA for Neo-link, Disposable Neonatal Air Way Connector.
| Device ID | K952824 |
| 510k Number | K952824 |
| Device Name: | NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR |
| Classification | Connector, Airway (extension) |
| Applicant | INTERTEX MEDICAL, INC. 16 RIVER ST. New Canaan, CT 06840 |
| Contact | Cary Jenkins |
| Correspondent | Cary Jenkins INTERTEX MEDICAL, INC. 16 RIVER ST. New Canaan, CT 06840 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-20 |
| Decision Date | 1995-07-20 |