FDA 510(k), K083153, ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007
FDA 510(k), K083153, ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007
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510(K) Number: K083153
Device Name: ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007
Manufacturer: HOLLISTER, INC.
Device Classification Name: tubes, gastrointestinal (and accessories)
Regulation Number: 876.5980
Classification Product Code: KNT
Date Received: 10/24/2008
Decision Date: 02/04/2009
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007
Manufacturer: HOLLISTER, INC.
Device Classification Name: tubes, gastrointestinal (and accessories)
Regulation Number: 876.5980
Classification Product Code: KNT
Date Received: 10/24/2008
Decision Date: 02/04/2009
Regulation Medical Specialty: Gastroenterology/Urology
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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