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FDA 510(k), K170210, PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0
FDA 510(k), K170210, PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0
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510(K) Number: K170210
Device Name: PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0
Manufacturer: Hilla Debby
Device Classification Name: System, Imaging, Gastrointestinal, Wireless, Capsule
Regulation Number: NEZ
Classification Product Code: 01/24/2017
Date Received: 09/01/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0
Manufacturer: Hilla Debby
Device Classification Name: System, Imaging, Gastrointestinal, Wireless, Capsule
Regulation Number: NEZ
Classification Product Code: 01/24/2017
Date Received: 09/01/2017
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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