510(k) K042684
K042684 is an FDA 510(k) premarket notification submitted by Well Lead Medical Instruments for the device "WELL LEAD TRACHEOSTOMY TUBE". The FDA issued a decision of Substantially Equivalent on February 17, 2005. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Well Lead Medical Instruments has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 2005
- Date Received
- September 29, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tracheostomy (W/Wo Connector)
- Device Class
- Class II
- Regulation Number
- 868.5800
- Review Panel
- AN
- Submission Type