The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Laryngeal Mirror Pre-warmer.
| Device ID | K855021 |
| 510k Number | K855021 |
| Device Name: | LARYNGEAL MIRROR PRE-WARMER |
| Classification | Unit, Examining/treatment, Ent |
| Applicant | JEDMED INSTRUMENT CO. 1430 HANLEY INDUSTRIAL CT. St. Louis, MO 63144 |
| Contact | Craig Rapp |
| Correspondent | Craig Rapp JEDMED INSTRUMENT CO. 1430 HANLEY INDUSTRIAL CT. St. Louis, MO 63144 |
| Product Code | ETF |
| CFR Regulation Number | 874.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-16 |
| Decision Date | 1986-03-20 |