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FDA 510(k) K001338, MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER, by Boston Scientific Corp

FDA 510(k) K001338, MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER, by Boston Scientific Corp

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510(K) Number: K001338
Device Name: MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER
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: 04/27/2000
Decision Date: 08/30/2000
Regulation Medical Specialty: Gastroenterology/Urology
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