FDA 510(k), K160707, CustomizedBone Service
FDA 510(k), K160707, CustomizedBone Service
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$149.00 USD
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$149.00 USD
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510(K) Number: K160707
Device Name: CustomizedBone Service
Manufacturer: Monticelli Marina
Device Classification Name: Plate, Cranioplasty, Preformed, Non-Alterable
Regulation Number: GXN
Classification Product Code: 03/14/2016
Date Received: 12/17/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: CustomizedBone Service
Manufacturer: Monticelli Marina
Device Classification Name: Plate, Cranioplasty, Preformed, Non-Alterable
Regulation Number: GXN
Classification Product Code: 03/14/2016
Date Received: 12/17/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology