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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K210748
Device Name Well-life TM Pen Needles, Well-life TM Safety Pen Needles
Applicant
W. L. Med Co., Ltd.
246, Geumgwangosan-ro, Geumgwang-yeon
Anseong-si,  KR 17535
Applicant Contact Ha Tae Joo
Correspondent
Plus Global
300, Atwood Street
Pittsburgh,  PA  15213
Correspondent Contact Peter Chung
Regulation Number880.5570
Classification Product Code
FMI  
Date Received03/12/2021
Decision Date 05/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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