Fungus Fighter Insoles
FDA 510(k) K780719 · Combe, Inc.
510(k) numberK780719
Submission
- Device name
- Fungus Fighter Insoles
- Applicant
- Combe, Inc.
Mchenry, IL, US - Received
- May 1, 1978
- Decision date
- October 10, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KYS – Insoles, Medical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6280
- Specialty
- General Hospital
More from Combe, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K171855 | External Moisturizing GelNUC · Special | 07/21/2017SE |
| K150615 | Vaginal Moisturizing GelNUC · Traditional | 05/01/2015SE |
| K141718 | Internal Hydrating GelNUC · Traditional | 11/13/2014SE |
| K942203 | OTC Denture CleanserEFT · Traditional | 08/10/1994SE |
| K925259 | CFR MonographEFT · Traditional | 01/11/1993SE |
| K863375 | Sea-BondKXX · Traditional | 09/19/1986SE |
| K770413 | Cushions, Denture Adhesive, All-DayEHS · Traditional | 06/24/1977SE |
| K770175 | Sea-Bond Adhevise Denture CushionsKKX · Traditional | 02/04/1977SE |
Questions and answers
When was Fungus Fighter Insoles cleared by the FDA?
Fungus Fighter Insoles (K780719) received a 510(k) decision of Substantially Equivalent on October 10, 1978, 162 days after the submission was received.
What is the product code of K780719?
The FDA product code is KYS – Insoles, Medical, a Class I (low risk) device regulated under 21 CFR 880.6280.