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FDA 510(k), K131855, PENTAX VIDEO COLONOSCOPES (EC FAMILY)
FDA 510(k), K131855, PENTAX VIDEO COLONOSCOPES (EC FAMILY)
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510(K) Number: K131855
Device Name: PENTAX VIDEO COLONOSCOPES (EC FAMILY)
Manufacturer: PENTAX MEDICAL COMPANY
Device Classification Name: colonoscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FDF
Date Received: 06/21/2013
Decision Date: 04/09/2014
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: PENTAX VIDEO COLONOSCOPES (EC FAMILY)
Manufacturer: PENTAX MEDICAL COMPANY
Device Classification Name: colonoscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FDF
Date Received: 06/21/2013
Decision Date: 04/09/2014
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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