FDA 510(k), K183016, SteriCap Mini Needle
FDA 510(k), K183016, SteriCap Mini Needle
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510(K) Number: K183016
Device Name: SteriCap Mini Needle
Manufacturer: OcuJet, LLC
Device Classification Name: needle, hypodermic, single lumen
Regulation Number: 880.5570
Classification Product Code: FMI
Date Received: 10/31/2018
Decision Date: 05/07/2019
Regulation Medical Specialty: General Hospital
Device Name: SteriCap Mini Needle
Manufacturer: OcuJet, LLC
Device Classification Name: needle, hypodermic, single lumen
Regulation Number: 880.5570
Classification Product Code: FMI
Date Received: 10/31/2018
Decision Date: 05/07/2019
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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