FDA 510(k) Application Details - K241612

Device Classification Name Bronchoscope (Flexible Or Rigid)

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510(K) Number K241612
Device Name Bronchoscope (Flexible Or Rigid)
Applicant Hunan Vathin Medical Instrument Co.Ltd
1/F, Building 12, Innovation and Entrepreneurship Service Ce
nter No 9 Chuanqi west road, Jiuhua Economic Development Zon
Xiangtan 411100 CN
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Contact Charlene Du
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Regulation Number 874.4680

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Classification Product Code EOQ
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Date Received 06/05/2024
Decision Date 10/29/2024
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

FDA Source Information for K241612


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