JOSTRA MECC SYSTEM


Device Classification Name

pump, blood, cardiopulmonary bypass, non-roller type

510(k) Number K023132
Device Name JOSTRA MECC SYSTEM
Original Applicant
JOSTRA AG
2828 n. crescent ridge dr.
the woodlands, 
TX 
77381

Original Contact kathleen johnson
Regulation Number 870.4360
Classification Product Code
KFM  
Date Received 09/20/2002
Decision Date 12/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No