MAPERSOL


Device Classification Name

system, perfusion, kidney

510(k) Number K080432
Device Name MAPERSOL
Applicant
PRESERVATION SOLUTIONS, INC.
4250 grove street
denver, 
CO 
80211

Applicant Contact neil burris
Correspondent
PRESERVATION SOLUTIONS, INC.
4250 grove street
denver, 
CO 
80211

Correspodent Contact neil burris
Regulation Number 876.5880
Classification Product Code
KDN  
Date Received 02/19/2008
Decision Date 08/08/2008
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