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510(k) K220204

Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle by Anhui Tiankang Medical Technology Co., Ltd. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2022
Date Received
January 25, 2022
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

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  • K191644 — TK Safety Needle (August 6, 2020)
  • K191642 — TK Sterile Piston Syringe without Needle (January 6, 2020)

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