The following data is part of a premarket notification filed by Med-plastics Intl., Inc. with the FDA for Connectors And Airway Extensions.
| Device ID | K931038 |
| 510k Number | K931038 |
| Device Name: | CONNECTORS AND AIRWAY EXTENSIONS |
| Classification | Connector, Airway (extension) |
| Applicant | MED-PLASTICS INTL., INC. 5668 WEST 73RD. ST. Indianapolis, IN 46278 |
| Contact | Michael Campbell |
| Correspondent | Michael Campbell MED-PLASTICS INTL., INC. 5668 WEST 73RD. ST. Indianapolis, IN 46278 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-01 |
| Decision Date | 1993-04-08 |