510(k) K211753

Sterile Syringe With Safety Needle by Jiangxi Hongda Medical Equipment Group , Ltd. — Product Code MEG

K211753 is an FDA 510(k) premarket notification submitted by Jiangxi Hongda Medical Equipment Group , Ltd. for the device "Sterile Syringe With Safety Needle". The FDA issued a decision of Substantially Equivalent on Oct 14, 2021. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Jiangxi Hongda Medical Equipment Group , Ltd. has 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 14, 2021
Date Received
Jun 7, 2021
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
510(k)