JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G


Device Classification Name

catheter,intravascular,therapeutic,short-term less than 30 days

510(k) Number K010410
Device Name JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G
Original Applicant
JMS CO., LTD.
12-17, kako-machi, naka-ku
hiroshima, 

JP

730-8652

Original Contact keisuke uratomi
Regulation Number 880.5200
Classification Product Code
FOZ  
Subsequent Product Code
FIE  
Date Received 02/12/2001
Decision Date 06/20/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No