The following data is part of a premarket notification filed by Kells Medical, Inc. with the FDA for Lucae's Ear & Nasal Applicators.
| Device ID | K832667 |
| 510k Number | K832667 |
| Device Name: | LUCAE'S EAR & NASAL APPLICATORS |
| Classification | Applicator, Ent |
| Applicant | KELLS MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KCJ |
| CFR Regulation Number | 874.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-09 |
| Decision Date | 1983-09-29 |