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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 K253629
Device Name Momcozy Nasal Aspirator (BN007)
Applicant
Shenzhen Root Innovation Technology Co., Ltd.
#2-201, Floor 2, Hasee Computer Bldg.
# 2 Beier Rd.,Bantian St., Longgang District
Shenzhen,  CN 518129
Applicant Contact Rex Hsieh
Correspondent
Shenzhen Root Innovation Technology Co., Ltd.
#2-201, Floor 2, Hasee Computer Bldg.
# 2 Beier Rd.,Bantian St., Longgang District
Shenzhen,  CN 518129
Correspondent Contact Rex Hsieh
Regulation Number878.4780
Classification Product Code
BTA  
Date Received11/19/2025
Decision Date 05/26/2026
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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