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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 K241852
Device Name Nasal Aspirator (NS 13)
Applicant
Avita Corporation
9f, #78, Sec.1, Kwang Fu Rd., Sanchong Dist.,
New Taipei City,  TW 24158
Applicant Contact Maggie Chao
Correspondent
Avita Corporation
9f, #78, Sec.1, Kwang Fu Rd., Sanchong Dist.,
New Taipei City,  TW 24158
Correspondent Contact Maggie Chao
Regulation Number878.4780
Classification Product Code
BTA  
Date Received06/27/2024
Decision Date 12/31/2024
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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