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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: 06/06/2001
Date Received: 01/23/2002
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: EXEL COMFORTPOINT INSULIN PEN NEEDLE
Manufacturer: ARMAND HAMID
Device Classification Name: Needle, Hypodermic, Single Lumen
Regulation Number: FMI
Classification Product Code: 06/06/2001
Date Received: 01/23/2002
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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