AMUKIN D


Device Classification Name

dialyzer reprocessing system

510(k) Number K992016
Device Name AMUKIN D
Applicant
AMUCHINA INTL., INC.
8-8 metropolitan ct.
gaithersburg, 
MD 
20878

Applicant Contact ludovico giavotto
Correspondent
AMUCHINA INTL., INC.
8-8 metropolitan ct.
gaithersburg, 
MD 
20878

Correspodent Contact ludovico giavotto
Classification Product Code
LIF  
Date Received 06/15/1999
Decision Date 01/10/2000
Decision

substantially equivalent

(SESE)

510k Review Panel

Gastroenterology/Urology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No