510(k) K152606

Jeesung Safety Syringe and Single Use Needles by Jeesung Medical Co., Ltd. — Product Code MEG

K152606 is an FDA 510(k) premarket notification submitted by Jeesung Medical Co., Ltd. for the device "Jeesung Safety Syringe and Single Use Needles". The FDA issued a decision of Substantially Equivalent on June 28, 2016. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Jeesung Medical Co., Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2016
Date Received
September 11, 2015
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