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FDA 510(k), K180233, Eviva Stereotactic Guided Breast Biopsy System
FDA 510(k), K180233, Eviva Stereotactic Guided Breast Biopsy System
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$149.00 USD
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510(K) Number: K180233
Device Name: Eviva Stereotactic Guided Breast Biopsy System
Manufacturer: Hologic, Inc
Device Classification Name: instrument, biopsy
Regulation Number: 876.1075
Classification Product Code: KNW
Date Received: 01/29/2018
Decision Date: 04/10/2018
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Eviva Stereotactic Guided Breast Biopsy System
Manufacturer: Hologic, Inc
Device Classification Name: instrument, biopsy
Regulation Number: 876.1075
Classification Product Code: KNW
Date Received: 01/29/2018
Decision Date: 04/10/2018
Regulation Medical Specialty: Gastroenterology/Urology
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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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