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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 K260134
Device Name Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)
Applicant
Shenzhen Root Innovation Technology Co., Ltd.
#2-201, Floor 2 Hasee Computer Bldg.
# 2 Beier Rd., Bantian St., Longgang
Shenzhen,  CN 518219
Applicant Contact Haiyan Wen
Correspondent
Shenzhen Root Innovation Technology Co., Ltd.
#2-201, Floor 2 Hasee Computer Bldg.
# 2 Beier Rd., Bantian St., Longgang
Shenzhen,  CN 518219
Correspondent Contact Haiyan Wen
Regulation Number878.4780
Classification Product Code
BTA  
Date Received01/16/2026
Decision Date 05/15/2026
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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