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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K214050
Device Name ENT Nasopharyngoscope and Accessories
Applicant
Medimaging Integrated Solution, Inc (Miis)
3f., #24-2, Industry E. Rd. Iv, Hsinchu Science Park
Hsinchu,  TW 30077
Applicant Contact Jung-Yi Yen
Correspondent
Medimaging Integrated Solution, Inc (Miis)
3f., #24-2, Industry E. Rd. Iv, Hsinchu Science Park
Hsinchu,  TW 30077
Correspondent Contact Jung-Yi Yen
Regulation Number874.4760
Classification Product Code
EOB  
Date Received12/27/2021
Decision Date 07/01/2022
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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