LIFEBRIDGE


Device Classification Name

pump, blood, cardiopulmonary bypass, non-roller type

510(k) Number K103357
Device Name LIFEBRIDGE
Applicant
LIFEBRIDGE MEDIZINTECHNIK AG
1282 round hill rd.
bryn mawr, 
PA 
19010

Applicant Contact kathleen johnson
Correspondent
LIFEBRIDGE MEDIZINTECHNIK AG
1282 round hill rd.
bryn mawr, 
PA 
19010

Correspodent Contact kathleen johnson
Regulation Number 870.4360
Classification Product Code
KFM  
Date Received 11/16/2010
Decision Date 12/27/2010
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

Yes