The following data is part of a premarket notification filed by Kelleher Corp. with the FDA for Nagashima Light Source Unit Sl-4.
| Device ID | K821708 |
| 510k Number | K821708 |
| Device Name: | NAGASHIMA LIGHT SOURCE UNIT SL-4 |
| Classification | Laryngoscope, Nasopharyngoscope |
| Applicant | KELLEHER CORP. 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 | 1982-06-09 |
| Decision Date | 1982-06-25 |