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FDA 510(k), K172483, Kopac Sterile Needle
FDA 510(k), K172483, Kopac Sterile Needle
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$49.00 USD
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510(K) Number: K172483
Device Name: Kopac Sterile Needle
Manufacturer: Poonglim Pharmatech Inc.
Device Classification Name: needle, hypodermic, single lumen
Regulation Number: 880.5570
Classification Product Code: FMI
Date Received: 08/16/2017
Decision Date: 06/21/2018
Regulation Medical Specialty: General Hospital
Device Name: Kopac Sterile Needle
Manufacturer: Poonglim Pharmatech Inc.
Device Classification Name: needle, hypodermic, single lumen
Regulation Number: 880.5570
Classification Product Code: FMI
Date Received: 08/16/2017
Decision Date: 06/21/2018
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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