FDA 510(k), K112342, FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM

FDA 510(k), K112342, FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM

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510(K) Number: K112342
Device Name: FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM
Manufacturer: KATRINA FIEDLER
Device Classification Name: Tubes, Gastrointestinal (And Accessories)
Regulation Number: KNT
Classification Product Code: 08/15/2011
Date Received: 04/26/2012
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology

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