The following data is part of a premarket notification filed by Combe, Inc. with the FDA for Fungus Fighter Insoles.
| Device ID | K780719 |
| 510k Number | K780719 |
| Device Name: | FUNGUS FIGHTER INSOLES |
| Classification | Insoles, Medical |
| Applicant | COMBE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KYS |
| CFR Regulation Number | 880.6280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-05-01 |
| Decision Date | 1978-10-10 |