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FDA 510(k), K050403, SPYGLASS DIRECT VISULATION PROBE
FDA 510(k), K050403, SPYGLASS DIRECT VISULATION PROBE
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510(K) Number: K050403
Device Name: SPYGLASS DIRECT VISULATION PROBE
Manufacturer: BOSTON SCIENTIFIC CORP.
Device Classification Name: mini endoscope, gastroenterology-urology
Regulation Number: 876.1500
Classification Product Code: ODF
Date Received: 02/17/2005
Decision Date: 03/04/2005
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: SPYGLASS DIRECT VISULATION PROBE
Manufacturer: BOSTON SCIENTIFIC CORP.
Device Classification Name: mini endoscope, gastroenterology-urology
Regulation Number: 876.1500
Classification Product Code: ODF
Date Received: 02/17/2005
Decision Date: 03/04/2005
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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