510(k) K141092
K141092 is an FDA 510(k) premarket notification submitted by Cavex Holland BV for the device "MARK3". The FDA issued a decision of Substantially Equivalent on December 4, 2014. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Cavex Holland BV has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 2014
- Date Received
- April 28, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Impression
- Device Class
- Class II
- Regulation Number
- 872.3660
- Review Panel
- DE
- Submission Type