VASC-ALERT


Device Classification Name

accessories, blood circuit, hemodialysis

510(k) Number K030456
Device Name VASC-ALERT
Applicant
VASC-ALERT L.L.C.
1807 w. sunnyside ave.
suite 301
chicago, 
IL 
60640

Applicant Contact john kennedy
Correspondent
VASC-ALERT L.L.C.
1807 w. sunnyside ave.
suite 301
chicago, 
IL 
60640

Correspodent Contact john kennedy
Regulation Number 876.5820
Classification Product Code
KOC  
Date Received 02/11/2003
Decision Date 07/11/2003
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