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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 K142764
Device Name KYOLING CPR Mask with Oxygen Port and Without Oxygen Port
Applicant
Hangzhou Jinlin Medical Appliances Co., Ltd.
# 9 16th Ave. Hangzhou Economic &
Technological Development Zone
Hangzhou,  CN 310018
Applicant Contact Lydia HE
Correspondent
Osmunda Medical Device Consulting Co., Ltd.
7th Floor Jingui Business Buildng # 982 Cogyuan Rd.
Baiyun District
Guangzhou,  CN 510420
Correspondent Contact Mike Gu
Regulation Number868.5870
Classification Product Code
CBP  
Date Received09/25/2014
Decision Date 07/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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