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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tympanostomy
510(k) Number K233658
Device Name Biowy Tym Tube (TT)
Applicant
Biowy Corporation
27031 Vista Terrace
Lake Forest,  CA  92630
Applicant Contact Zhihua Lu
Correspondent
Biowy Corporation
27031 Vista Terrace
Lake Forest,  CA  92630
Correspondent Contact Zhihua Lu
Regulation Number874.3880
Classification Product Code
ETD  
Date Received11/15/2023
Decision Date 02/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
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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