The following data is part of a premarket notification filed by Scientific Sales Intl., Inc. with the FDA for Salem/resce Intubation Guide.
| Device ID | K802416 |
| 510k Number | K802416 |
| Device Name: | SALEM/RESCE INTUBATION GUIDE |
| Classification | Stylet, Tracheal Tube |
| Applicant | SCIENTIFIC SALES INTL., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BSR |
| CFR Regulation Number | 868.5790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-06 |
| Decision Date | 1980-10-23 |