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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Allergen And Vaccine Delivery Needles
510(k) Number K222385
Device Name Bifurcated Needle
Applicant
Anhui Tiankang Medical Technology Co., Ltd.
# 228, Weiyi Rd., Economic Development Zone
Tianchang,  CN 239300
Applicant Contact Zhang Yong
Correspondent
Anhui Tiankang Medical Technology Co., Ltd.
# 228, Weiyi Rd., Economic Development Zone
Tianchang,  CN 239300
Correspondent Contact Zhang Yong
Regulation Number880.5570
Classification Product Code
SCL  
Date Received08/08/2022
Decision Date 12/06/2022
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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