FDA 510(k), K050578, COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE
FDA 510(k), K050578, COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE
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510(K) Number: K050578
Device Name: COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE
Manufacturer: COOK IRELAND LTD
Device Classification Name: unit, electrosurgical, endoscopic (with or without accessories)
Regulation Number: 876.4300
Classification Product Code: KNS
Date Received: 03/07/2005
Decision Date: 04/22/2005
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE
Manufacturer: COOK IRELAND LTD
Device Classification Name: unit, electrosurgical, endoscopic (with or without accessories)
Regulation Number: 876.4300
Classification Product Code: KNS
Date Received: 03/07/2005
Decision Date: 04/22/2005
Regulation Medical Specialty: Gastroenterology/Urology
- 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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