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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 K234096
Device Name MonoStereo
Applicant
Medicaltek Co., Ltd.
4f., #26 Keya Rd. Daya Dist.
Taichung City,  TW 428
Applicant Contact Shen Ching (James) Yeh
Correspondent
Arazy Group Consultants, Inc.
3422 Leonardo Lane
New Smyrna,  FL  32168
Correspondent Contact Raymond Kelly
Regulation Number874.4760
Classification Product Code
EOB  
Date Received12/26/2023
Decision Date 09/19/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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