QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030


Device Classification Name

oxygenator, cardiopulmonary bypass

510(k) Number K030264
Device Name QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030
Original Applicant
JOSTRA AG
hechinger strasse 38
hirrlingen, 

DE

72145

Original Contact katrin schwenkglenks
Regulation Number 870.4350
Classification Product Code
DTZ  
Date Received 01/27/2003
Decision Date 02/26/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No