FDA 510(k) Application Details - K230536

Device Classification Name Nasopharyngoscope (Flexible Or Rigid)

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510(K) Number K230536
Device Name Nasopharyngoscope (Flexible Or Rigid)
Applicant Hunan Vathin Medical Instrument Co., Ltd.
1/F, Building 12, Innovation and Entrepreneurship Service
Center No 9 Chuanqi west road, Jiuhua Economic Development
Xiangtan 411100 CN
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Contact Du Jing
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Regulation Number 874.4760

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Classification Product Code EOB
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Date Received 02/27/2023
Decision Date 06/14/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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