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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nebulizer (direct patient interface)
510(k) Number K192633
Device Name GUS831 Compressor Nebulizer
Applicant
Globalcare Medical Technology Co., Ltd.
7th Building, 39 Middle Industrial Main Road, European
Industrial Zone
Xiaolan Town, Zhongshan City,  CN 528415
Applicant Contact Janice Deng
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
No. A415, Block A, Nanshan Medical device industrial park,
Nanshan District
Shenzhen,  CN 518067
Correspondent Contact Kevin Wang
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/23/2019
Decision Date 05/01/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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