STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)


Device Classification Name

control, pump speed, cardiopulmonary bypass

510(k) Number K103468
Device Name STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)
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 870.4380
Classification Product Code
DWA  
Date Received 11/24/2010
Decision Date 01/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No