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510(k) K191642

TK Sterile Piston Syringe without Needle by Anhui Tiankang Medical Technology Co., Ltd. — Product Code FMF

Clearance Details

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

Device Classification

Device Name
Syringe, Piston
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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  • K191640 — TK Intravascular Administration Set (August 26, 2020)
  • K191644 — TK Safety Needle (August 6, 2020)

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