FDA 510(k), K192266, M. Blue Adjustable Shunt System
FDA 510(k), K192266, M. Blue Adjustable Shunt System
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510(K) Number: K192266
Device Name: M. Blue Adjustable Shunt System
Manufacturer: Kathy A Racosky
Device Classification Name: Shunt, Central Nervous System And Components
Regulation Number: JXG
Classification Product Code: 08/21/2019
Date Received: 11/21/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: M. Blue Adjustable Shunt System
Manufacturer: Kathy A Racosky
Device Classification Name: Shunt, Central Nervous System And Components
Regulation Number: JXG
Classification Product Code: 08/21/2019
Date Received: 11/21/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
- 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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