STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER


Device Classification Name

console, heart-lung machine, cardiopulmonary bypass

510(k) Number K080832
Device Name STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER
Applicant
SORIN GROUP DEUTSCHLAND GMBH
49 plain street
north attleboro, 
MA 
02760

Applicant Contact rosina robinson
Correspondent
SORIN GROUP DEUTSCHLAND GMBH
49 plain street
north attleboro, 
MA 
02760

Correspodent Contact rosina robinson
Regulation Number 870.4220
Classification Product Code
DTQ  
Date Received 03/25/2008
Decision Date 07/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No