The following data is part of a premarket notification filed by Machida America, Inc. with the FDA for Flexible Nasopharyngo-laryngoscope #.
| Device ID | K821181 |
| 510k Number | K821181 |
| Device Name: | FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE # |
| Classification | Laryngoscope, Nasopharyngoscope |
| Applicant | MACHIDA AMERICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EQN |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-27 |
| Decision Date | 1982-05-13 |