510(k) K053316
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 2006
- Date Received
- November 29, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sleeve, Limb, Compressible
- Device Class
- Class II
- Regulation Number
- 870.5800
- Review Panel
- CV
- Submission Type