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FDA 510(k), K142688, Echotip Procore HD Ultrasound Biopsy Needle
FDA 510(k), K142688, Echotip Procore HD Ultrasound Biopsy Needle
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$49.00 USD
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510(K) Number: K142688
Device Name: Echotip Procore HD Ultrasound Biopsy Needle
Manufacturer: Nora O'Connor
Device Classification Name: Biopsy Needle
Regulation Number: FCG
Classification Product Code: KXA
Date Received: 09/22/2014
Decision Date: 12/19/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Echotip Procore HD Ultrasound Biopsy Needle
Manufacturer: Nora O'Connor
Device Classification Name: Biopsy Needle
Regulation Number: FCG
Classification Product Code: KXA
Date Received: 09/22/2014
Decision Date: 12/19/2014
Decision: Substantially Equivalent (SESE)
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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