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FDA 510(k), K100081, ENTEROSCOPY OVERTUBE, MODEL 00712140
FDA 510(k), K100081, ENTEROSCOPY OVERTUBE, MODEL 00712140
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510(K) Number: K100081
Device Name: ENTEROSCOPY OVERTUBE, MODEL 00712140
Manufacturer: BOB BISHUI
Device Classification Name: Endoscopic Access Overtube, Gastroenterology-Urology
Regulation Number: FED
Classification Product Code: 01/12/2010
Date Received: 04/12/2010
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: ENTEROSCOPY OVERTUBE, MODEL 00712140
Manufacturer: BOB BISHUI
Device Classification Name: Endoscopic Access Overtube, Gastroenterology-Urology
Regulation Number: FED
Classification Product Code: 01/12/2010
Date Received: 04/12/2010
Decision Date: Substantially Equivalent (SESE)
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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