510(k) K113247
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2012
- Date Received
- November 2, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Cartridge
- Device Class
- Class II
- Regulation Number
- 872.6770
- Review Panel
- DE
- Submission Type