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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 K222547
FOIA Releasable 510(k) K222547
Device Name Electric nasal aspirator
Applicant
Shenzhen XinLianFeng Technology CO.,LTD
No.5, Tongxi Road, Pingdong Community, Pingdi Street,
Longgang District
Shenzhen,  CN 518000
Applicant Contact Ma Qiang
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co.Ltd
Room 1407, Jingting Building, Dongzhou Community,
Guangming Street, Guangming District
Shenzhen,  CN 518107
Correspondent Contact Reanny Wang
Regulation Number878.4780
Classification Product Code
BTA  
Date Received08/23/2022
Decision Date 10/20/2022
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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