The following data is part of a premarket notification filed by Humboldt Products with the FDA for Tekna Med Myringotomy Dispos-oto Kit.
| Device ID | K813616 |
| 510k Number | K813616 |
| Device Name: | TEKNA MED MYRINGOTOMY DISPOS-OTO KIT |
| Classification | Tube, Tympanostomy |
| Applicant | HUMBOLDT PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-29 |
| Decision Date | 1982-01-22 |