The following data is part of a premarket notification filed by Vitaid, Ltd. with the FDA for Wire Reinforced Endotracheal Tube.
Device ID | K932647 |
510k Number | K932647 |
Device Name: | WIRE REINFORCED ENDOTRACHEAL TUBE |
Classification | Tube, Tracheal (w/wo Connector) |
Applicant | VITAID, LTD. 269 PORTAGE RD. Lewiston, NY 14092 |
Contact | William G Stewart |
Correspondent | William G Stewart VITAID, LTD. 269 PORTAGE RD. Lewiston, NY 14092 |
Product Code | BTR |
CFR Regulation Number | 868.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-02 |
Decision Date | 1993-11-02 |