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510(k) K192679

Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use by Gemtier Medical (Shanghai), Inc. — Product Code MEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2020
Date Received
September 26, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Antistick
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Gemtier Medical (Shanghai), Inc.

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  • K202493 — Medical Face Mask (February 4, 2021)
  • K202331 — Medical Face Mask (February 2, 2021)
  • K170276 — Safety Blood Collection Device for Single Use (December 11, 2017)

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