NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG


Device Classification Name

oxygenator, cardiopulmonary bypass

510(k) Number K072362
Device Name NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG
Applicant
NOVALUNG GMBH
49 plain street
north attleboro, 
MA 
02760

Applicant Contact rosina robinson
Correspondent
NOVALUNG GMBH
49 plain street
north attleboro, 
MA 
02760

Correspodent Contact rosina robinson
Regulation Number 870.4350
Classification Product Code
DTZ  
Date Received 08/22/2007
Decision Date 10/23/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes