FDA 510(k), K854404, ROTEX SCREW BIOPSY NEEDLE
FDA 510(k), K854404, ROTEX SCREW BIOPSY NEEDLE
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510(K) Number: K854404
Device Name: ROTEX SCREW BIOPSY NEEDLE
Manufacturer: MEADOX SURGIMED, INC.
Device Classification Name: biopsy needle
Regulation Number: 876.1075
Classification Product Code: FCG
Date Received: 11/01/1985
Decision Date: 12/02/1985
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: ROTEX SCREW BIOPSY NEEDLE
Manufacturer: MEADOX SURGIMED, INC.
Device Classification Name: biopsy needle
Regulation Number: 876.1075
Classification Product Code: FCG
Date Received: 11/01/1985
Decision Date: 12/02/1985
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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