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FDA 510(k), K182265, CodMan Certas Plus Programmable Valve
FDA 510(k), K182265, CodMan Certas Plus Programmable Valve
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510(K) Number: K182265
Device Name: CodMan Certas Plus Programmable Valve
Manufacturer: Nancy MacDonald
Device Classification Name: Shunt, Central Nervous System And Components
Regulation Number: JXG
Classification Product Code: KXA
Date Received: 08/21/2018
Decision Date: 11/20/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: CodMan Certas Plus Programmable Valve
Manufacturer: Nancy MacDonald
Device Classification Name: Shunt, Central Nervous System And Components
Regulation Number: JXG
Classification Product Code: KXA
Date Received: 08/21/2018
Decision Date: 11/20/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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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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