510(k) K860620
K860620 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "SHAMPAINE RADI-OP MODEL 1700RC". The FDA issued a decision of Substantially Equivalent on April 8, 1986. The device falls under product code KXJ (Table, Radiologic), a Class II device regulated under 21 CFR 892.1980. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 1986
- Date Received
- February 19, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Radiologic
- Device Class
- Class II
- Regulation Number
- 892.1980
- Review Panel
- RA
- Submission Type