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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 K201397
Device Name Ultrasonic Mesh Nebulizer
Shenzhen Ivankaca Technology Co., Ltd
3/F, Building B, No. 45 lixin road, NanWan, Longgang,
Shenzhen, Guangdong
Shenzhen,  CN 518100
Applicant Contact Sam Wong
Shenzhen Hlongmed Biotech Co., Ltd.
1201, Haosheng Business Center, 4096 Dongbin Road, Nanshan,
Shenzhen, P.R.C
Shenzhen,  CN 518054
Correspondent Contact Long Yang
Regulation Number868.5630
Classification Product Code
Date Received05/28/2020
Decision Date 06/14/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No