MEDI PEN NEEDLE

Needle, Hypodermic, Single Lumen

SHANGHAI CARELIFE INTERNATIONAL TRADING CO., LTD.

The following data is part of a premarket notification filed by Shanghai Carelife International Trading Co., Ltd. with the FDA for Medi Pen Needle.

Pre-market Notification Details

Device IDK131954
510k NumberK131954
Device Name:MEDI PEN NEEDLE
ClassificationNeedle, Hypodermic, Single Lumen
Applicant SHANGHAI CARELIFE INTERNATIONAL TRADING CO., LTD. ROOM 1707, YINQIAO BLDG, NO 58 JINXIN ROAD Shanghai, Pudong,  CN 201206
ContactWilliam Conety
CorrespondentWilliam Conety
SHANGHAI CARELIFE INTERNATIONAL TRADING CO., LTD. ROOM 1707, YINQIAO BLDG, NO 58 JINXIN ROAD Shanghai, Pudong,  CN 201206
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-27
Decision Date2014-05-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00616784702834 K131954 000
00616784702735 K131954 000
00616784702636 K131954 000
00616784702537 K131954 000
00616784702438 K131954 000

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