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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 K220126
Device Name Geonic Nasal Aspirator, Geonic Nasal Cleaner
Applicant
Geon Corporation
No. 12, Gung Ye Road
Hsi Hu, Chang Hwa Hsien,  TW 514
Applicant Contact Henry Chen
Correspondent
AlfaBeta Clinical Research Co., Ltd.
Rm. R103, 1F., No. 8, Sec. 2, Shengyi Rd.,
Chupei City, Hsinchu County,  TW 30261
Correspondent Contact Wan-Chi Chang
Regulation Number878.4780
Classification Product Code
BTA  
Subsequent Product Code
KMA  
Date Received01/18/2022
Decision Date 02/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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