Jeesung Safety Syringe and Single Use Needles

FDA 510(k) K152606 · Jeesung Medical Co., Ltd.

Substantially Equivalent

510(k) numberK152606

Submission

Device name
Jeesung Safety Syringe and Single Use Needles
Applicant
Jeesung Medical Co., Ltd.
Daejeon, KR
Received
September 11, 2015
Decision date
June 28, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MEG – Syringe, Antistick
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5860
Specialty
General Hospital

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More from Jiangsu Kangbao Medical Equipment Co., Ltd.

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Questions and answers

When was Jeesung Safety Syringe and Single Use Needles cleared by the FDA?

Jeesung Safety Syringe and Single Use Needles (K152606) received a 510(k) decision of Substantially Equivalent on June 28, 2016, 291 days after the submission was received.

What is the product code of K152606?

The FDA product code is MEG – Syringe, Antistick, a Class II (moderate risk) device regulated under 21 CFR 880.5860.