510(k) K141640

AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE by Shantou Wealy Medical Instrument Co.,Ltd — Product Code MEG

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