STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES

Syringe, Piston

WUXI YUSHOU MEDICAL APPLICANCES CO., LTD

The following data is part of a premarket notification filed by Wuxi Yushou Medical Applicances Co., Ltd with the FDA for Sterile Piston Hypodermic Syringes (with/without Needle), Hypodermic Needles.

Pre-market Notification Details

Device IDK130230
510k NumberK130230
Device Name:STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES
ClassificationSyringe, Piston
Applicant WUXI YUSHOU MEDICAL APPLICANCES CO., LTD 215# XIGANG ROAD DONGBEITANG Wuxi City, Jiangsu,  CN 214191
ContactGarfield Wang
CorrespondentGarfield Wang
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD 215# XIGANG ROAD DONGBEITANG Wuxi City, Jiangsu,  CN 214191
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-01-29
Decision Date2013-11-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00370393562011 K130230 000
00370393000353 K130230 000
10370393140018 K130230 000
00370393552012 K130230 000
0037039300445 K130230 000
0037039300469 K130230 000
10370393557014 K130230 000
00370393000537 K130230 000
10370393560014 K130230 000
00370393000513 K130230 000
00370393000339 K130230 000

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