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FDA 510(k), K083058, IBA PROTON THERAPY SYSTEM - PROTEUS 235
FDA 510(k), K083058, IBA PROTON THERAPY SYSTEM - PROTEUS 235
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510(K) Number: K083058
Device Name: IBA PROTON THERAPY SYSTEM - PROTEUS 235
Manufacturer: JOHN B REISS
Device Classification Name: System, Radiation Therapy, Charged-Particle, Medical
Regulation Number: LHN
Classification Product Code: 10/14/2008
Date Received: 04/15/2009
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: IBA PROTON THERAPY SYSTEM - PROTEUS 235
Manufacturer: JOHN B REISS
Device Classification Name: System, Radiation Therapy, Charged-Particle, Medical
Regulation Number: LHN
Classification Product Code: 10/14/2008
Date Received: 04/15/2009
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- 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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