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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 K180863
Device Name FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator
Applicant
TaiDoc Technology Corporation
6F, No.127, Wugong 2nd Rd., Wugu District
New Taipei City,  TW 24888
Applicant Contact Sylvia Liu
Correspondent
TaiDoc Technology Corporation
6F, No.127, Wugong 2nd Rd., Wugu District
New Taipei City,  TW 24888
Correspondent Contact Sylvia Liu
Regulation Number878.4780
Classification Product Code
BTA  
Date Received04/02/2018
Decision Date 12/19/2018
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
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