The following data is part of a premarket notification filed by Machida America, Inc. with the FDA for Model Ent-4l-flexible Nasopharyngo-.
| Device ID | K821182 |
| 510k Number | K821182 |
| Device Name: | MODEL ENT-4L-FLEXIBLE NASOPHARYNGO- |
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04580137732518 | K821182 | 000 |
| 04580137732501 | K821182 | 000 |
| 04580137730217 | K821182 | 000 |
| 04580137730200 | K821182 | 000 |
| 04580137733041 | K821182 | 000 |
| 04580137733034 | K821182 | 000 |