510(k) K960312
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 1996
- Date Received
- January 22, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Vessel, Surgical
- Device Class
- Class II
- Regulation Number
- 870.4475
- Review Panel
- CV
- Submission Type