The following data is part of a premarket notification filed by Coast Medical Corp. with the FDA for Disposable Cuffed Endotracheal Tube.
| Device ID | K925781 |
| 510k Number | K925781 |
| Device Name: | DISPOSABLE CUFFED ENDOTRACHEAL TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | COAST MEDICAL CORP. 1060 NORTH BATAVIA UNIT H Orange, CA 92667 |
| Contact | Douglas R Mongeon |
| Correspondent | Douglas R Mongeon COAST MEDICAL CORP. 1060 NORTH BATAVIA UNIT H Orange, CA 92667 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-12 |
| Decision Date | 1993-04-19 |