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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 K260147
Device Name Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)
Applicant
Shenzhen Kingboom Technology Co., Ltd.
#201, 2nd Floor, #5, Tongxin Rd., Pingdong Community, Pingdi
Shenzhen,  CN 518117
Applicant Contact Qiang Ma
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.
Rm. 1509, Jingting Bldg., Dongzhou Community, Guangming St.,
Shenzhen,  CN 518107
Correspondent Contact Reanny Wang
Regulation Number878.4780
Classification Product Code
BTA  
Date Received01/20/2026
Decision Date 03/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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