NOVOFLO CATHETER LT


Device Classification Name

catheter, hemodialysis, implanted

510(k) Number K072499
Device Name NOVOFLO CATHETER LT
Applicant
NOVOSCI, INC.
2828 north crescent ridge dr.
the woodlands, 
TX 
77381

Applicant Contact david makanani
Correspondent
NOVOSCI, INC.
2828 north crescent ridge dr.
the woodlands, 
TX 
77381

Correspodent Contact david makanani
Regulation Number 876.5540
Classification Product Code
MSD  
Date Received 09/05/2007
Decision Date 10/30/2007
Decision

substantially equivalent – kit

(SESK)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No