510(k) K030585
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2003
- Date Received
- February 24, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coating, Filling Material, Resin
- Device Class
- Class II
- Regulation Number
- 872.3310
- Review Panel
- DE
- Submission Type