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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K202060
Device Name Disposable IV catheter
Applicant
Shinva Ande Healthcare Apparatus Co., Ltd.
#77 Development Zone N. Rd.,
Zibo,  CN 255086
Applicant Contact Liang Wanjie
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui, #5, Yihe N. Rd.
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received07/27/2020
Decision Date 07/23/2021
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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