XTRA


Device Classification Name

apparatus, autotransfusion

510(k) Number K112245
Device Name XTRA
Applicant
SORIN GROUP ITALIA S.R.L
parexel consulting
195 west street
waltham, 
MA 
02451

Applicant Contact barry sall
Correspondent
SORIN GROUP ITALIA S.R.L
parexel consulting
195 west street
waltham, 
MA 
02451

Correspodent Contact barry sall
Regulation Number 868.5830
Classification Product Code
CAC  
Date Received 08/04/2011
Decision Date 09/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No