The following data is part of a premarket notification filed by Unomedical Sdn Bhd with the FDA for Euromedical Reinforced Endotracheal Tube.
Device ID | K962389 |
510k Number | K962389 |
Device Name: | EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE |
Classification | Tube, Tracheal (w/wo Connector) |
Applicant | UNOMEDICAL SDN BHD 40178 U.S. 19 NORTH Tarpon Springs, FL 34689 |
Contact | Patrick J Lamb |
Correspondent | Patrick J Lamb UNOMEDICAL SDN BHD 40178 U.S. 19 NORTH Tarpon Springs, FL 34689 |
Product Code | BTR |
CFR Regulation Number | 868.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-20 |
Decision Date | 1996-11-21 |