510(k) K860020
K860020 is an FDA 510(k) premarket notification submitted by Adel Medical , Ltd. for the device "MINOR SURGERY LIGHT MODEL 2112". The FDA issued a decision of Substantially Equivalent on January 24, 1986. The device falls under product code FSS (Light, Surgical, Floor Standing), a Class II device regulated under 21 CFR 878.4580. Adel Medical , Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 24, 1986
- Date Received
- January 3, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Surgical, Floor Standing
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type