MODIFICATION TO JMS APHERESIS NEEDLE

Needle, Fistula

JMS CO., LTD.

The following data is part of a premarket notification filed by Jms Co., Ltd. with the FDA for Modification To Jms Apheresis Needle.

Pre-market Notification Details

Device IDK000843
510k NumberK000843
Device Name:MODIFICATION TO JMS APHERESIS NEEDLE
ClassificationNeedle, Fistula
Applicant JMS CO., LTD. 12-17, KAKO-MACHI, NAKA-KU Hiroshima,  JP 730-8652
ContactKeisuke Uratomi
CorrespondentKeisuke Uratomi
JMS CO., LTD. 12-17, KAKO-MACHI, NAKA-KU Hiroshima,  JP 730-8652
Product CodeFIE  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-15
Decision Date2000-04-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.