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FDA 510(k), K161409, M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem
FDA 510(k), K161409, M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem
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510(K) Number: K161409
Device Name: M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem
Manufacturer: Mermaid Medical A/S
Device Classification Name: instrument, biopsy
Regulation Number: 876.1075
Classification Product Code: KNW
Date Received: 05/20/2016
Decision Date: 08/02/2016
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem
Manufacturer: Mermaid Medical A/S
Device Classification Name: instrument, biopsy
Regulation Number: 876.1075
Classification Product Code: KNW
Date Received: 05/20/2016
Decision Date: 08/02/2016
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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