MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900


Device Classification Name

tubes, gastrointestinal (and accessories)

510(k) Number K080679
Device Name MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
Applicant
VIASYS MEDSYSTEMS
100 chaddick dr.
wheeling, 
IL 
60090

Applicant Contact stephanie wasielewski
Correspondent
VIASYS MEDSYSTEMS
100 chaddick dr.
wheeling, 
IL 
60090

Correspodent Contact stephanie wasielewski
Regulation Number 876.5980
Classification Product Code
KNT  
Date Received 03/10/2008
Decision Date 06/27/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No