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510(k) K222739

Disposable Insulin Pen Needle by Hantech Medical Device Co., Ltd. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2023
Date Received
September 9, 2022
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

Other clearances by Hantech Medical Device Co., Ltd.

  • K231363 — Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, (September 27, 2023)
  • K222672 — Disposable Insulin Syringe (March 6, 2023)
  • K221038 — Disposable Medical Masks (September 1, 2022)
  • K220603 — Disposable Medical Safety Hypodermic Needle (August 23, 2022)

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