FDA 510(k), K170008, Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set
FDA 510(k), K170008, Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set
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510(K) Number: K170008
Device Name: Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set
Manufacturer: COOK INCORPORATED
Device Classification Name: instrument, biopsy
Regulation Number: 876.1075
Classification Product Code: KNW
Date Received: 01/03/2017
Decision Date: 02/28/2017
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set
Manufacturer: COOK INCORPORATED
Device Classification Name: instrument, biopsy
Regulation Number: 876.1075
Classification Product Code: KNW
Date Received: 01/03/2017
Decision Date: 02/28/2017
Regulation Medical Specialty: Gastroenterology/Urology
- 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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