Well-life TM Pen Needles, Well-life TM Safety Pen Needles

Needle, Hypodermic, Single Lumen

W. L. Med Co., Ltd.

The following data is part of a premarket notification filed by W. L. Med Co., Ltd. with the FDA for Well-life Tm Pen Needles, Well-life Tm Safety Pen Needles.

Pre-market Notification Details

Device IDK210748
510k NumberK210748
Device Name:Well-life TM Pen Needles, Well-life TM Safety Pen Needles
ClassificationNeedle, Hypodermic, Single Lumen
Applicant W. L. Med Co., Ltd. 246, Geumgwangosan-ro, Geumgwang-yeon Anseong-si,  KR 17535
ContactHa Tae Joo
CorrespondentPeter Chung
Plus Global 300, Atwood Street Pittsburgh,  PA  15213
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-12
Decision Date2022-05-25

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