510(k) K962084
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 1997
- Date Received
- May 29, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type