KG MEDIX DISPOSABLE SYRING, 1,3,5,10, 20, 30, 50 ML’S,KG MEDIX


Device Classification Name

needle, hypodermic, single lumen

510(k) Number K022057
Device Name KG MEDIX DISPOSABLE SYRING, 1,3,5,10, 20, 30, 50 ML’S,KG MEDIX
Original Applicant
KYUNG GI MEDICAL IND. CO., LTD
529-4 yulsaeng-ri daegot-myun
kimpo-si, kyunggi-do, 

KR

4152367

Original Contact byung doo jee
Regulation Number 880.5570
Classification Product Code
FMI  
Subsequent Product Code
FMF  
Date Received 06/24/2002
Decision Date 11/22/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No