510(k) K895369
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1989
- Date Received
- August 29, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Marker, Ostia, Aorto-Saphenous Vein
- Device Class
- Class II
- Regulation Number
- 878.4650
- Review Panel
- CV
- Submission Type