FDA 510(k), K052194, SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR
FDA 510(k), K052194, SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR
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510(K) Number: K052194
Device Name: SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR
Manufacturer: BOSTON SCIENTIFIC CORP.
Device Classification Name: mini endoscope, gastroenterology-urology
Regulation Number: 876.1500
Classification Product Code: ODF
Date Received: 08/11/2005
Decision Date: 08/24/2005
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR
Manufacturer: BOSTON SCIENTIFIC CORP.
Device Classification Name: mini endoscope, gastroenterology-urology
Regulation Number: 876.1500
Classification Product Code: ODF
Date Received: 08/11/2005
Decision Date: 08/24/2005
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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