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FDA 510(k), K153486, Affirm Prone Biopsy System
FDA 510(k), K153486, Affirm Prone Biopsy System
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510(K) Number: K153486
Device Name: Affirm Prone Biopsy System
Manufacturer: Sarah Fairfield
Device Classification Name: System, X-Ray, Mammographic
Regulation Number: IZH
Classification Product Code: 12/04/2015
Date Received: 04/01/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: Affirm Prone Biopsy System
Manufacturer: Sarah Fairfield
Device Classification Name: System, X-Ray, Mammographic
Regulation Number: IZH
Classification Product Code: 12/04/2015
Date Received: 04/01/2016
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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