510(k) K023540
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 2003
- Date Received
- October 22, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cover, Barrier, Protective
- Device Class
- Class II
- Regulation Number
- 878.4370
- Review Panel
- HO
- Submission Type