The following data is part of a premarket notification filed by Stebar Instrument Corp. with the FDA for Schroeder Oral/nasal Directional Stylette.
| Device ID | K935797 |
| 510k Number | K935797 |
| Device Name: | SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE |
| Classification | Stylet, Tracheal Tube |
| Applicant | STEBAR INSTRUMENT CORP. 3066 THREE MILE RD/ M/W/ Grand Rapids, MI 49504 |
| Contact | Steven M Daugherty |
| Correspondent | Steven M Daugherty STEBAR INSTRUMENT CORP. 3066 THREE MILE RD/ M/W/ Grand Rapids, MI 49504 |
| Product Code | BSR |
| CFR Regulation Number | 868.5790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-02 |
| Decision Date | 1994-01-12 |