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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 K212514
Device Name Safety Pen Needle for Single Use, Insulin Pen Needles
Applicant
Berpu Medical Technology Co., Ltd.
# 14 Xingji Rd., Yongxing St., Longwan District
Wenzhou,  CN 325000
Applicant Contact Buxin Yu
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/10/2021
Decision Date 04/29/2022
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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