NOVOSCI READY SYSTEM, MODEL RS-200

Device Classification Name

pump, blood, cardiopulmonary bypass, non-roller type

510(k) Number K033270
Device Name NOVOSCI READY SYSTEM, MODEL RS-200
Applicant
NOVOSCI CORP.
2828 north crescent ridge dr.
the woodlands, 
TX 
77381 -3902

Applicant Contact leann latham
Correspondent
NOVOSCI CORP.
2828 north crescent ridge dr.
the woodlands, 
TX 
77381 -3902

Correspodent Contact leann latham
Regulation Number 870.4360
Classification Product Code
KFM  
Date Received 10/10/2003
Decision Date 02/13/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No