510(k) K951886
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 1995
- Date Received
- April 24, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Vacuum Sample, With Anticoagulant
- Device Class
- Class II
- Regulation Number
- 862.1675
- Review Panel
- CH
- Submission Type