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FDA 510(k), K102581, DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305
FDA 510(k), K102581, DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305
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510(K) Number: K102581
Device Name: DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305
Manufacturer: BYRNE MEDICAL INC.
Device Classification Name: endoscope channel accessory
Regulation Number: 876.1500
Classification Product Code: ODC
Date Received: 09/08/2010
Decision Date: 11/08/2010
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305
Manufacturer: BYRNE MEDICAL INC.
Device Classification Name: endoscope channel accessory
Regulation Number: 876.1500
Classification Product Code: ODC
Date Received: 09/08/2010
Decision Date: 11/08/2010
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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