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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 K192464
Device Name Injection Pen Needle
Applicant
Gangan Medical Technology Jiangsu Co., Ltd.
1st-4th Flr, Bldg. G130, Fifth Phase Of Standard Workshop
Medical City
Taizhou City,  CN 225300
Applicant Contact Wu Shuhui
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
R912, B#15, Xiyuehui, #5, Yihe N. Rd., Fangshan
District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/09/2019
Decision Date 08/25/2020
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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