510(k) K141640
K141640 is an FDA 510(k) premarket notification submitted by Shantou Wealy Medical Instrument Co.,Ltd for the device "AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE". The FDA issued a decision of Substantially Equivalent on November 19, 2014. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Shantou Wealy Medical Instrument Co.,Ltd has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 2014
- Date Received
- June 19, 2014
- 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