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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 K253107
Device Name Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)
Applicant
Shenzhen Dongjiang Technology Co., Ltd.
Rm. 301, Bldg. 9, # 6 Hongji Rd., Longxin Community
Baolong St.
Shenzhen,  CN 518000
Applicant Contact Junjie Wei
Correspondent
Shenzhen Dongjiang Technology Co., Ltd.
Rm. 301, Bldg. 9, # 6 Hongji Rd., Longxin Community
Baolong St.
Shenzhen,  CN 518000
Correspondent Contact Jenny Wu
Regulation Number878.4780
Classification Product Code
BTA  
Date Received09/24/2025
Decision Date 04/14/2026
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
Predetermined Change
Control Plan Authorized		 No
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