PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM


Device Classification Name

apparatus, autotransfusion

510(k) Number K022167
Device Name PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM
Original Applicant
PALL CORP.
2200 northern blvd.
east hills, 
NY 
11548

Original Contact leonard s berman
Regulation Number 868.5830
Classification Product Code
CAC  
Date Received 07/03/2002
Decision Date 03/07/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No