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FDA 510(k), K090116, FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15
FDA 510(k), K090116, FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15
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510(K) Number: K090116
Device Name: FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15
Manufacturer: FUJINON, INC.
Device Classification Name: colonoscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FDF
Date Received: 01/21/2009
Decision Date: 04/22/2009
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15
Manufacturer: FUJINON, INC.
Device Classification Name: colonoscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FDF
Date Received: 01/21/2009
Decision Date: 04/22/2009
Regulation Medical Specialty: Gastroenterology/Urology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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