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510(k) K181069

Disposable Insulin Pen Needle by Zhejiang Kindly Medical Devices Co., Ltd. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2018
Date Received
April 23, 2018
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 Zhejiang Kindly Medical Devices Co., Ltd.

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  • K172763 — Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle (June 4, 2018)
  • K171518 — Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Need (January 5, 2018)

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