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FDA 510(k), K181460, OnePacs System
FDA 510(k), K181460, OnePacs System
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510(K) Number: K181460
Device Name: OnePacs System
Manufacturer: Justin Falk
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: 06/04/2018
Date Received: 10/11/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: OnePacs System
Manufacturer: Justin Falk
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: 06/04/2018
Date Received: 10/11/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- 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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