FDA 510(k), K162516, BD Pen Needle
FDA 510(k), K162516, BD Pen Needle
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510(K) Number: K162516
Device Name: BD Pen Needle
Manufacturer: BECTON, DICKINSON AND COMPANY
Device Classification Name: needle, hypodermic, single lumen
Regulation Number: 880.5570
Classification Product Code: FMI
Date Received: 09/09/2016
Decision Date: 12/09/2016
Regulation Medical Specialty: General Hospital
Device Name: BD Pen Needle
Manufacturer: BECTON, DICKINSON AND COMPANY
Device Classification Name: needle, hypodermic, single lumen
Regulation Number: 880.5570
Classification Product Code: FMI
Date Received: 09/09/2016
Decision Date: 12/09/2016
Regulation Medical Specialty: General Hospital
- 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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