510(k) K020333
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 2002
- Date Received
- January 31, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injector And Syringe, Angiographic
- Device Class
- Class II
- Regulation Number
- 870.1650
- Review Panel
- HO
- Submission Type