510(k) K954103
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 1995
- Date Received
- August 31, 1995
- 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