3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES


Device Classification Name

reservoir, blood, cardiopulmonary bypass

510(k) Number K072697
Device Name 3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES
Applicant
3T MEDICAL SYSTEMS, LLC
12553 s. wamblee valley road
conifer, 
CO 
80433

Applicant Contact robert p eaton
Correspondent
3T MEDICAL SYSTEMS, LLC
12553 s. wamblee valley road
conifer, 
CO 
80433

Correspodent Contact robert p eaton
Regulation Number 870.4400
Classification Product Code
DTN  
Subsequent Product Code
DTP  
Date Received 09/24/2007
Decision Date 12/20/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No