510(k) K152879
K152879 is an FDA 510(k) premarket notification submitted by Shina Med Corporation for the device "Sure-Fine Insulin Syringes". The FDA issued a decision of Substantially Equivalent on September 9, 2016. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Shina Med Corporation has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 2016
- Date Received
- September 30, 2015
- 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