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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 K242028
Device Name Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)
Applicant
Dongguanshi Yiyingmei Technology Co., Ltd.
301 Rm., Bldg. #1, # 3 W. Second St.,
Wusha Xingfazhong Rd., Chang 'An Town
Dongguan,  CN 523000
Applicant Contact Junbing Chen
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90, Qia
Shenzhen,  CN 518052
Correspondent Contact Youshan Gong
Regulation Number878.4780
Classification Product Code
BTA  
Date Received07/11/2024
Decision Date 11/19/2024
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
Predetermined Change
Control Plan Authorized		 No
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