BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)


Device Classification Name

apparatus, hemoperfusion, sorbent

510(k) Number K992196
Device Name BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)
Applicant
HEMOCLEANSE, INC.
2700 kent ave.
west lafayette, 
IN 
47906

Applicant Contact stephen r ash
Correspondent
HEMOCLEANSE, INC.
2700 kent ave.
west lafayette, 
IN 
47906

Correspodent Contact stephen r ash
Regulation Number 876.5870
Classification Product Code
FLD  
Subsequent Product Code
FKT  
Date Received 06/30/1999
Decision Date 09/10/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No