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FDA 510(k), K172938, Disposable Sterile Needle
FDA 510(k), K172938, Disposable Sterile Needle
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510(K) Number: K172938
Device Name: Disposable Sterile Needle
Manufacturer: Jun Lu
Device Classification Name: Needle, Hypodermic, Single Lumen
Regulation Number: FMI
Classification Product Code: KXA
Date Received: 09/26/2017
Decision Date: 06/14/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: Disposable Sterile Needle
Manufacturer: Jun Lu
Device Classification Name: Needle, Hypodermic, Single Lumen
Regulation Number: FMI
Classification Product Code: KXA
Date Received: 09/26/2017
Decision Date: 06/14/2018
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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