IBAG


Device Classification Name

collector, urine, (and accessories) for indwelling catheter

510(k) Number K110518
Device Name IBAG
Applicant
FUTURE PATH MEDICAL, LLC
8870 ravello ct
naples, 
FL 
34114

Applicant Contact daniel kamm
Correspondent
FUTURE PATH MEDICAL, LLC
8870 ravello ct
naples, 
FL 
34114

Correspodent Contact daniel kamm
Regulation Number 876.5250
Classification Product Code
KNX  
Subsequent Product Code
EXS  
Date Received 02/23/2011
Decision Date 06/24/2011
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