FDA 510(k), K112226, HYDROCOIL EMBOLIC SYSTEM (HES)
FDA 510(k), K112226, HYDROCOIL EMBOLIC SYSTEM (HES)
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510(K) Number: K112226
Device Name: HYDROCOIL EMBOLIC SYSTEM (HES)
Manufacturer:
Device Classification Name: Device, Neurovascular Embolization
Regulation Number: 882.5950
Classification Product Code: HCG
Date Received: 08/03/2011
Decision Date: 09/29/2011
Regulation Medical Specialty: Neurology
Device Name: HYDROCOIL EMBOLIC SYSTEM (HES)
Manufacturer:
Device Classification Name: Device, Neurovascular Embolization
Regulation Number: 882.5950
Classification Product Code: HCG
Date Received: 08/03/2011
Decision Date: 09/29/2011
Regulation Medical Specialty: Neurology