ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000


Device Classification Name

apparatus, autotransfusion

510(k) Number K022348
Device Name ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000
Original Applicant
INTERPORE CROSS INTL.
181 technology dr.
irvine, 
CA 
92618 -2402

Original Contact prosie rey-fessler
Regulation Number 868.5830
Classification Product Code
CAC  
Subsequent Product Code
FJI  
Date Received 07/19/2002
Decision Date 08/15/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No