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FDA 510(k) Application Details - K191828
Device Classification Name
Bronchoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K191828
Device Name
Bronchoscope (Flexible Or Rigid)
Applicant
Hunan Vathin Medical Instrument Co., Ltd.
1/F, Building 12, No 9 Chuanqi west road,
Jiuhua Economic Development Zone
Xiangtan 411100 CN
Other 510(k) Applications for this Company
Contact
Yun Feng
Other 510(k) Applications for this Contact
Regulation Number
874.4680
More FDA Info for this Regulation Number
Classification Product Code
EOQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/08/2019
Decision Date
02/13/2020
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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