510(k) K780719
K780719 is an FDA 510(k) premarket notification submitted by Combe, Inc. for the device "FUNGUS FIGHTER INSOLES". The FDA issued a decision of Substantially Equivalent on October 10, 1978. The device falls under product code KYS (Insoles, Medical), a Class I device regulated under 21 CFR 880.6280. Combe, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 1978
- Date Received
- May 1, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Insoles, Medical
- Device Class
- Class I
- Regulation Number
- 880.6280
- Review Panel
- HO
- Submission Type