FDA 510(k), K202279, Insignis Subcutaneous Needle Sets
FDA 510(k), K202279, Insignis Subcutaneous Needle Sets
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510(K) Number: K202279
Device Name: Insignis Subcutaneous Needle Sets
Manufacturer: Innovative Health Sciences, LLC
Device Classification Name: Set, Administration, Intravascular
Regulation Number: 880.5440
Classification Product Code: FPA
Date Received: 08/11/2020
Decision Date: 08/13/2021
Regulation Medical Specialty: General Hospital
Device Name: Insignis Subcutaneous Needle Sets
Manufacturer: Innovative Health Sciences, LLC
Device Classification Name: Set, Administration, Intravascular
Regulation Number: 880.5440
Classification Product Code: FPA
Date Received: 08/11/2020
Decision Date: 08/13/2021
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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