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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 K241202
Device Name Electric nasal aspirator (HTD2601US)
Applicant
Hetaida Technology Co., Ltd.
Rm.801, 802, 803, 804, 901, 2# Bldg. Scientific Research Ctr
Songhu Intelligent Valley, #6 Minfu Rd., Liaobu Town
Dongguan City,  CN 523423
Applicant Contact Tom Chen
Correspondent
Hetaida Technology Co., Ltd.
Rm.801, 802, 803, 804, 901, 2# Bldg. Scientific Research Ctr
Songhu Intelligent Valley, #6 Minfu Rd., Liaobu Town
Dongguan City,  CN 523423
Correspondent Contact Tom Chen
Regulation Number878.4780
Classification Product Code
BTA  
Date Received04/30/2024
Decision Date 07/01/2024
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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