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FDA 510(k), K170803, HydroMARK Breast Biopsy Site Markers
FDA 510(k), K170803, HydroMARK Breast Biopsy Site Markers
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$149.00 USD
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510(K) Number: K170803
Device Name: HydroMARK Breast Biopsy Site Markers
Manufacturer: Shawna Rose
Device Classification Name: Marker, Radiographic, Implantable
Regulation Number: NEU
Classification Product Code: 03/17/2017
Date Received: 06/15/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: HydroMARK Breast Biopsy Site Markers
Manufacturer: Shawna Rose
Device Classification Name: Marker, Radiographic, Implantable
Regulation Number: NEU
Classification Product Code: 03/17/2017
Date Received: 06/15/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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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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