The following data is part of a premarket notification filed by Michigan Instruments, Inc. with the FDA for Laryngostat Laryngoscope Handle.
| Device ID | K895954 |
| 510k Number | K895954 |
| Device Name: | LARYNGOSTAT LARYNGOSCOPE HANDLE |
| Classification | Laryngoscope, Rigid |
| Applicant | MICHIGAN INSTRUMENTS, INC. 6300 - 28TH ST. SE Grand Rapids, MI 49506 |
| Contact | Mitchell Baldwin |
| Correspondent | Mitchell Baldwin MICHIGAN INSTRUMENTS, INC. 6300 - 28TH ST. SE Grand Rapids, MI 49506 |
| Product Code | CCW |
| CFR Regulation Number | 868.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-11 |
| Decision Date | 1989-10-30 |