510(k) K050411
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 2005
- Date Received
- February 17, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tourniquet, Pneumatic
- Device Class
- Class I
- Regulation Number
- 878.5910
- Review Panel
- SU
- Submission Type