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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K192285
Device Name CPR Face Shield
Applicant
Firstar Healthcare Company Limited (Guangzhou)
Rm.901, Bldg. #2,Headquarters Center,
Tian’An High-Tech Ecological Park
Guangzhou,  CN 511400
Applicant Contact Alice Zhao
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm.608,# 738,Shangcheng Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number868.5870
Classification Product Code
CBP  
Date Received08/22/2019
Decision Date 11/25/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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