510(k) K860519
K860519 is an FDA 510(k) premarket notification submitted by F. & F. Koenigkramer for the device "RELIANCE MODEL 200 PODIATRY CHAIR". The FDA issued a decision of Substantially Equivalent on February 19, 1986. The device falls under product code LGX (Table, Examination, Medical, Powered), a Class I device regulated under 21 CFR 878.4960. F. & F. Koenigkramer has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 1986
- Date Received
- February 11, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Examination, Medical, Powered
- Device Class
- Class I
- Regulation Number
- 878.4960
- Review Panel
- HO
- Submission Type