FUNGUS FIGHTER INSOLES— 510(k) K780719
Substantially EquivalentCombe, Inc.
FDA 510(k) clearance K780719 for FUNGUS FIGHTER INSOLES, Substantially Equivalent on 1978-10-10. Applicant: Combe, Inc.. Device class: 1.
Clearance details
- Applicant
- Combe, Inc.
- Product code
- Code KYS
- Device class
- Class 1
- Regulation
- 21 CFR 880.6280
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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