The following data is part of a premarket notification filed by Imed Corp. with the FDA for Introducer For Endotracheal Tube.
| Device ID | K820451 |
| 510k Number | K820451 |
| Device Name: | INTRODUCER FOR ENDOTRACHEAL TUBE |
| Classification | Forceps, Tube Introduction |
| Applicant | IMED CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BWB |
| CFR Regulation Number | 868.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-18 |
| Decision Date | 1982-03-26 |