SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET


Device Classification Name

microfilter, blood transfusion

510(k) Number K022477
Device Name SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET
Original Applicant
SUMMIT MEDICAL LTD.
business & technology centre
bessemer drive
stevenage hertfordshire, 

GB

sgi 2dx

Original Contact neil r armstrong
Regulation Number 880.5440
Classification Product Code
CAK  
Date Received 07/29/2002
Decision Date 10/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No