CODAN SAFEFEED ENTERAL FEEDING RESERVOIR


Device Classification Name

tubes, gastrointestinal (and accessories)

510(k) Number K112268
Device Name CODAN SAFEFEED ENTERAL FEEDING RESERVOIR
Applicant
CODAN US CORP.
3511 west sunflower ave.
santa ana, 
CA 
92704 -6944

Applicant Contact jeff nielsen
Regulation Number 876.5980
Classification Product Code
KNT  
Date Received 08/08/2011
Decision Date 03/19/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

statement

statement

Type Traditional
Reviewed by Third Party Yes

Combination Product

No