15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET

Device Classification Name

catheter, hemodialysis, implanted

510(k) Number K071422
Device Name 15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET
Applicant
REX MEDICAL
55 northern blvd.
suite 200
great neck, 
NY 
11021

Applicant Contact susan d goldstein-falk
Correspondent
REX MEDICAL
55 northern blvd.
suite 200
great neck, 
NY 
11021

Correspodent Contact susan d goldstein-falk
Regulation Number 876.5540
Classification Product Code
MSD  
Date Received 05/22/2007
Decision Date 08/22/2007
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