510(k) K163162

Sterile Hypodermic Safety Syringes for Single Use by Jiangxi Hongda Medical Equipment Group , Ltd. — Product Code MEG

K163162 is an FDA 510(k) premarket notification submitted by Jiangxi Hongda Medical Equipment Group , Ltd. for the device "Sterile Hypodermic Safety Syringes for Single Use". The FDA issued a decision of Substantially Equivalent on Mar 20, 2017. 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
Mar 20, 2017
Date Received
Nov 10, 2016
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)