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510(k) K212518

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2022
Date Received
August 10, 2021
Clearance Type
Special
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

Other clearances by Jeesung Medical Co., Ltd.

  • K152166 — JSM Insulin Pen Needle (July 11, 2016)
  • K152606 — Jeesung Safety Syringe and Single Use Needles (June 28, 2016)

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