FDA 510(k), K103254, PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE
FDA 510(k), K103254, PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE
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510(K) Number: K103254
Device Name: PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE
Manufacturer:
Device Classification Name: Tubes, Gastrointestinal (And Accessories)
Regulation Number: 876.5980
Classification Product Code: KNT
Date Received: 11/03/2010
Decision Date: 01/31/2011
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE
Manufacturer:
Device Classification Name: Tubes, Gastrointestinal (And Accessories)
Regulation Number: 876.5980
Classification Product Code: KNT
Date Received: 11/03/2010
Decision Date: 01/31/2011
Regulation Medical Specialty: Gastroenterology/Urology