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510(k) K191639

TK Insulin Syringe with/without Saftey Retractable Device by Anhui Tiankang Medical Technology Co., Ltd. — Product Code MEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2020
Date Received
June 19, 2019
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

Other clearances by Anhui Tiankang Medical Technology Co., Ltd.

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  • K212368 — Surgical Face Mask (October 24, 2021)
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  • K191640 — TK Intravascular Administration Set (August 26, 2020)
  • K191644 — TK Safety Needle (August 6, 2020)
  • K191642 — TK Sterile Piston Syringe without Needle (January 6, 2020)

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