510(k) K211482
K211482 is an FDA 510(k) premarket notification submitted by Shandong Qinkai Medical Industry Co., Ltd. for the device "Disposable Syringe with Needle". The FDA issued a decision of Substantially Equivalent on Jan 24, 2022. 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
- Jan 24, 2022
- Date Received
- May 12, 2021
- 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
- 510(k)