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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K233901
Device Name Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)
Applicant
Shenzhen Desida Technology Co., Ltd.
5th Floor, Building A, Sanmin Industrial Zone, Shilongzai,
Shuitian Community, Shiyan Street, Baoan District
Shenzhen,  CN 518109
Applicant Contact Shuangcheng Yuan
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm 2401 Zhenye International Business Center, No. 3101-90
Qianhai Road
Shenzhen,  CN 518052
Correspondent Contact Youshan Gong
Regulation Number878.4780
Classification Product Code
BTA  
Date Received12/11/2023
Decision Date 03/20/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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