510(k) K011419
K011419 is an FDA 510(k) premarket notification submitted by Cavex Holland BV for the device "CAVEX COLORCHANGE". The FDA issued a decision of Substantially Equivalent on July 16, 2001. 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
- July 16, 2001
- Date Received
- May 9, 2001
- 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