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FDA 510(k), K060007, BD AUTOSHIELD PEN NEEDLE
FDA 510(k), K060007, BD AUTOSHIELD PEN NEEDLE
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510(K) Number: K060007
Device Name: BD AUTOSHIELD PEN NEEDLE
Manufacturer: JAMES W HAYNES
Device Classification Name: Needle, Hypodermic, Single Lumen
Regulation Number: FMI
Classification Product Code: KXA
Date Received: 01/03/2006
Decision Date: 03/23/2006
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: BD AUTOSHIELD PEN NEEDLE
Manufacturer: JAMES W HAYNES
Device Classification Name: Needle, Hypodermic, Single Lumen
Regulation Number: FMI
Classification Product Code: KXA
Date Received: 01/03/2006
Decision Date: 03/23/2006
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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- 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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