The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Endotracheal Tube Guide Or Intubation Stylette.
| Device ID | K854632 |
| 510k Number | K854632 |
| Device Name: | ENDOTRACHEAL TUBE GUIDE OR INTUBATION STYLETTE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | RESPIRATORY SUPPORT PRODUCTS, INC. 3183-D AIRWAY AVE. Costa Mesa, CA 92626 |
| Contact | Steve Georgevich |
| Correspondent | Steve Georgevich RESPIRATORY SUPPORT PRODUCTS, INC. 3183-D AIRWAY AVE. Costa Mesa, CA 92626 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-21 |
| Decision Date | 1986-01-03 |