EXEL I.V. BLOOD LINE SET


Device Classification Name

set, tubing, blood, with and without anti-regurgitation valve

510(k) Number K992039
Device Name EXEL I.V. BLOOD LINE SET
Applicant
EXELINT INTL. CO.
5840 west centinela ave.
los angeles, 
CA 
90045

Applicant Contact armand hamid
Correspondent
EXELINT INTL. CO.
5840 west centinela ave.
los angeles, 
CA 
90045

Correspodent Contact armand hamid
Regulation Number 876.5820
Classification Product Code
FJK  
Date Received 06/17/1999
Decision Date 02/10/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No