510(k) K191490
K191490 is an FDA 510(k) premarket notification submitted by Jiangsu Caina Medical Co.,Ltd for the device "Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe". The FDA issued a decision of Substantially Equivalent on October 3, 2019. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Jiangsu Caina Medical Co.,Ltd has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2019
- Date Received
- June 5, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Antistick
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type