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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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$662.05 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
Total pages: 2467
Fully redacted pages: 2180
Content pages: 287
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