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FDA 510(k), K103512, AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
FDA 510(k), K103512, AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
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510(K) Number: K103512
Device Name: AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
Manufacturer: HOLOGIC, INC.
Device Classification Name: system, x-ray, mammographic
Regulation Number: 892.1710
Classification Product Code: IZH
Date Received: 11/30/2010
Decision Date: 01/07/2011
Regulation Medical Specialty: Radiology
Device Name: AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
Manufacturer: HOLOGIC, INC.
Device Classification Name: system, x-ray, mammographic
Regulation Number: 892.1710
Classification Product Code: IZH
Date Received: 11/30/2010
Decision Date: 01/07/2011
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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