510(k) K942303
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 1994
- Date Received
- May 13, 1994
- 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