The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Laser Resistant Tracheal Tube W/murphy Eye.
| Device ID | K844564 |
| 510k Number | K844564 |
| Device Name: | ARGYLE LASER RESISTANT TRACHEAL TUBE W/MURPHY EYE |
| Classification | Tube, Tracheal (w/wo Connector) |
| 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 | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-23 |
| Decision Date | 1985-02-12 |