FDA 510(k), K011757, EXEL COMFORTPOINT INSULIN PEN NEEDLE

FDA 510(k), K011757, EXEL COMFORTPOINT INSULIN PEN NEEDLE

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510(K) Number: K011757
Device Name: EXEL COMFORTPOINT INSULIN PEN NEEDLE
Manufacturer: ARMAND HAMID
Device Classification Name: Needle, Hypodermic, Single Lumen
Regulation Number: FMI
Classification Product Code: KXA
Date Received: 06/06/2001
Decision Date: 01/23/2002
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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