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FDA 510(k), K151635, CapsoCam (SV-1)
FDA 510(k), K151635, CapsoCam (SV-1)
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510(K) Number: K151635
Device Name: CapsoCam (SV-1)
Manufacturer: CapsoVision, Inc.
Device Classification Name: system, imaging, gastrointestinal, wireless, capsule
Regulation Number: 876.1300
Classification Product Code: NEZ
Date Received: 06/17/2015
Decision Date: 02/09/2016
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: CapsoCam (SV-1)
Manufacturer: CapsoVision, Inc.
Device Classification Name: system, imaging, gastrointestinal, wireless, capsule
Regulation Number: 876.1300
Classification Product Code: NEZ
Date Received: 06/17/2015
Decision Date: 02/09/2016
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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