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FDA 510(k), K133251, BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
FDA 510(k), K133251, BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
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510(K) Number: K133251
Device Name: BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
Manufacturer: MICHELE DAVIS
Device Classification Name: Tubes, Gastrointestinal (And Accessories)
Regulation Number: KNT
Classification Product Code: KXA
Date Received: 10/22/2013
Decision Date: 05/09/2014
Decision Date: Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
Manufacturer: MICHELE DAVIS
Device Classification Name: Tubes, Gastrointestinal (And Accessories)
Regulation Number: KNT
Classification Product Code: KXA
Date Received: 10/22/2013
Decision Date: 05/09/2014
Decision Date: Substantially Equivalent - Kit (SESK)
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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