510(k) K011452
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 2001
- Date Received
- May 11, 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