510(k) K040633
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 2004
- Date Received
- March 10, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type