FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM


Device Classification Name

tubes, gastrointestinal (and accessories)

510(k) Number K112342
Device Name FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM
Applicant
CONVATEC INC
200 headquarters park drive
skillman, 
NJ 
08558

Applicant Contact katrina fiedler
Correspondent
CONVATEC INC
200 headquarters park drive
skillman, 
NJ 
08558

Correspodent Contact katrina fiedler
Regulation Number 876.5980
Classification Product Code
KNT  
Date Received 08/15/2011
Decision Date 04/26/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No