510(k) K102666
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 2010
- Date Received
- September 15, 2010
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Drape, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4370
- Review Panel
- HO
- Submission Type