The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Jet Tracheal Tube.
Device ID | K833807 |
510k Number | K833807 |
Device Name: | ARGYLE JET TRACHEAL TUBE |
Classification | Tube, Tracheal (w/wo Connector) |
Applicant | SHERWOOD MEDICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BTR |
CFR Regulation Number | 868.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-11-01 |
Decision Date | 1984-01-13 |