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510(k) K172483

Kopac Sterile Needle by Poonglim Pharmatech, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2018
Date Received
August 16, 2017
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 Poonglim Pharmatech, Inc.

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  • K210444 — EZ-Injec LDV Sterile Safety Needle (February 16, 2021)
  • K210443 — PLPT LDV (Low Dead Volume) Sterile Syringe (February 16, 2021)
  • K192222 — EZ-Inject Single use Needle (May 12, 2020)

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