FUNGUS FIGHTER INSOLES
FDA 510(k) clearance K780719 · decided 1978-10-10
Clearance details
- K-number
- K780719
- Device name
- FUNGUS FIGHTER INSOLES
- Applicant
- Combe, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-05-01
- Decision date
- 1978-10-10
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- KYS
- Device class
- 1
- Regulation number
- 880.6280
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.