The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle 15mm Swivel Connector.
| Device ID | K850625 |
| 510k Number | K850625 |
| Device Name: | ARGYLE 15MM SWIVEL CONNECTOR |
| Classification | Connector, Airway (extension) |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Contact | Frank J Fucile |
| Correspondent | Frank J Fucile SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-19 |
| Decision Date | 1985-03-21 |