SEDAT MYSHELL LITE


Device Classification Name

adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

510(k) Number K080472
Device Name SEDAT MYSHELL LITE
Applicant
SEDAT
8895 towne centre drive
105-416
san diego, 
CA 

Applicant Contact laetitia cousin
Correspondent
SEDAT
8895 towne centre drive
105-416
san diego, 
CA 

Correspodent Contact laetitia cousin
Regulation Number 870.4290
Classification Product Code
DTL  
Date Received 02/21/2008
Decision Date 04/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No