510(k) K103830
K103830 is an FDA 510(k) premarket notification submitted by Jiangsu Shenli Medical Production Factory for the device "JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK)". The FDA issued a decision of Substantially Equivalent on Jul 29, 2011. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 29, 2011
- Date Received
- Dec 30, 2010
- Clearance Type
- Abbreviated
- 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
- 510(k)