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FDA 510(k), K971125, ENDO SMARTCAP (100501)
FDA 510(k), K971125, ENDO SMARTCAP (100501)
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510(K) Number: K971125
Device Name: ENDO SMARTCAP (100501)
Manufacturer: ENDO SMART CAP CO.
Device Classification Name: endoscopic irrigation/suction system
Regulation Number: 876.1500
Classification Product Code: OCX
Date Received: 03/27/1997
Decision Date: 05/23/1997
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: ENDO SMARTCAP (100501)
Manufacturer: ENDO SMART CAP CO.
Device Classification Name: endoscopic irrigation/suction system
Regulation Number: 876.1500
Classification Product Code: OCX
Date Received: 03/27/1997
Decision Date: 05/23/1997
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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