JMS APHERESIS NEEDLE SET ACCORDION TYPE


Device Classification Name

needle, hypodermic, single lumen

510(k) Number K002394
Device Name JMS APHERESIS NEEDLE SET ACCORDION TYPE
Original Applicant
JMS CO., LTD.
12-17, kako-machi, naka-ku
hiroshima, 

JP

730-8652

Original Contact keisuke uratomi
Regulation Number 880.5570
Classification Product Code
FMI  
Subsequent Product Code
FIE  
Date Received 08/07/2000
Decision Date 09/05/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No