510(k) K870417
K870417 is an FDA 510(k) premarket notification submitted by North Coast Medi-Tek for the device "RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY". The FDA issued a decision of Substantially Equivalent on March 5, 1987. The device falls under product code FSM (Tray, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. North Coast Medi-Tek has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 1987
- Date Received
- February 3, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tray, Surgical, Instrument
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type