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FDA 510(k), K093665, ENDO SMARTCAP
FDA 510(k), K093665, ENDO SMARTCAP
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510(K) Number: K093665
Device Name: ENDO SMARTCAP
Manufacturer: BYRNE MEDICAL INC.
Device Classification Name: cystoscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FAJ
Date Received: 11/25/2009
Decision Date: 12/15/2009
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: ENDO SMARTCAP
Manufacturer: BYRNE MEDICAL INC.
Device Classification Name: cystoscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FAJ
Date Received: 11/25/2009
Decision Date: 12/15/2009
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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