FDA 510(k), CustomizedBone Service, Regulatory and Clinical Research Institute, Inc.
FDA 510(k), CustomizedBone Service, Regulatory and Clinical Research Institute, Inc.
Device Name: CustomizedBone Service
Manufacturer: Regulatory and Clinical Research Institute, Inc.
Device Classification Name: Plate, Cranioplasty, Preformed, Non-Alterable
Regulation Number: 882.5330
Classification Product Code: GXN
Date Received: 12/20/2019
Decision Date: 01/17/2020
Regulation Medical Specialty: Neurology
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