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510(k) K191644

TK Safety Needle by Anhui Tiankang Medical Technology Co., Ltd. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2020
Date Received
June 19, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

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  • K191640 — TK Intravascular Administration Set (August 26, 2020)
  • K191642 — TK Sterile Piston Syringe without Needle (January 6, 2020)

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