PERFADEX SOLUTION FOR LUNG PRESERVATION


Device Classification Name

system and accessories, isolated heart, transport and preservation

510(k) Number K022730
Device Name PERFADEX SOLUTION FOR LUNG PRESERVATION
Original Applicant
VITROLIFE AB
155 cider mill rd.
ringoes, 
NJ 
08551

Original Contact karl a posselt
Regulation Number 876.5880
Classification Product Code
MSB  
Date Received 08/16/2002
Decision Date 10/27/2003
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