510(k) K122416
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 2013
- Date Received
- August 8, 2012
- 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