The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Pediatric Double Swivel Connector.
| Device ID | K812000 |
| 510k Number | K812000 |
| Device Name: | PEDIATRIC DOUBLE SWIVEL CONNECTOR |
| Classification | Connector, Airway (extension) |
| Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-14 |
| Decision Date | 1981-08-03 |