The following data is part of a premarket notification filed by N-c-n Products Co. with the FDA for Cn Endotracheal Tube Holder.
Device ID | K921698 |
510k Number | K921698 |
Device Name: | CN ENDOTRACHEAL TUBE HOLDER |
Classification | Device, Fixation, Tracheal Tube |
Applicant | N-C-N PRODUCTS CO. 1315 GLENMORE CT. Barrington, IL 60010 |
Contact | Abdel Nouraldin |
Correspondent | Abdel Nouraldin N-C-N PRODUCTS CO. 1315 GLENMORE CT. Barrington, IL 60010 |
Product Code | CBH |
CFR Regulation Number | 868.5770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-08 |
Decision Date | 1992-09-15 |