FDA 510(k), K102082, EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470
FDA 510(k), K102082, EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470
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510(K) Number: K102082
Device Name: EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470
Manufacturer: BOSTON SCIENTIFIC CORP.
Device Classification Name: stents, drains and dilators for the biliary ducts
Regulation Number: 876.5010
Classification Product Code: FGE
Date Received: 07/26/2010
Decision Date: 08/23/2010
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470
Manufacturer: BOSTON SCIENTIFIC CORP.
Device Classification Name: stents, drains and dilators for the biliary ducts
Regulation Number: 876.5010
Classification Product Code: FGE
Date Received: 07/26/2010
Decision Date: 08/23/2010
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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