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FDA 510(k), K101428, OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET
FDA 510(k), K101428, OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET
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510(K) Number: K101428
Device Name: OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET
Manufacturer: OVESCO ENDOSCOPY AG
Device Classification Name: hemostatic metal clip for the gi tract
Regulation Number: 876.4400
Classification Product Code: PKL
Date Received: 05/21/2010
Decision Date: 12/01/2010
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET
Manufacturer: OVESCO ENDOSCOPY AG
Device Classification Name: hemostatic metal clip for the gi tract
Regulation Number: 876.4400
Classification Product Code: PKL
Date Received: 05/21/2010
Decision Date: 12/01/2010
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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