The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Concept Endotracheal Tube.
Device ID | K801213 |
510k Number | K801213 |
Device Name: | CONCEPT ENDOTRACHEAL TUBE |
Classification | Tube, Tracheal (w/wo Connector) |
Applicant | CONCEPT, INC. 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 | 1980-05-20 |
Decision Date | 1980-05-28 |