The following data is part of a premarket notification filed by Unomedical Sdn Bhd with the FDA for Endotracheal Tube.
Device ID | K951696 |
510k Number | K951696 |
Device Name: | ENDOTRACHEAL TUBE |
Classification | Tube, Tracheal (w/wo Connector) |
Applicant | UNOMEDICAL SDN BHD P.O. BOX NO. 18 SUNGEI PATANI KEDAH West Malaysia, MY |
Contact | Patrick J Lamb |
Correspondent | Patrick J Lamb UNOMEDICAL SDN BHD P.O. BOX NO. 18 SUNGEI PATANI KEDAH West Malaysia, MY |
Product Code | BTR |
CFR Regulation Number | 868.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-12 |
Decision Date | 1995-05-22 |