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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 K251450
Device Name Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009)
Applicant
Shenzhen Desida Technology Co., Ltd.
5th Floor, Bldg. A, Sanmin Industrial Zone, Shilongzai
Shuitian Community, Shiyan St., Baoan District
Shenzhen,  CN 518109
Applicant Contact Shuangcheng Yuan
Correspondent
Shenzhen Desida Technology Co., Ltd.
5th Floor, Bldg. A, Sanmin Industrial Zone, Shilongzai
Shuitian Community, Shiyan St., Baoan District
Shenzhen,  CN 518109
Correspondent Contact Shuangcheng Yuan
Regulation Number878.4780
Classification Product Code
BTA  
Date Received05/09/2025
Decision Date 06/06/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Ear Nose & Throat
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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