MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM


Device Classification Name

clamp, vascular

510(k) Number K080206
Device Name MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM
Applicant
RADI MEDICAL SYSTEMS AB
palmbladsgatan 10
uppsala, 

SE

s-754 50

Applicant Contact helene ekstrand
Correspondent
RADI MEDICAL SYSTEMS AB
palmbladsgatan 10
uppsala, 

SE

s-754 50

Correspodent Contact helene ekstrand
Regulation Number 870.4450
Classification Product Code
DXC  
Date Received 01/28/2008
Decision Date 02/26/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No