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FDA 510(k) Application Details - DEN230027
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN230027
Device Name
NaviCam ProScan
Applicant
Ankon Technologies Co., Ltd
B3-2, B3-3, D3-4 Biolake, No.666, Hi-Tech Road,
East Lake New, Technology Development Zone
Wuhan 430075 CN
Other 510(k) Applications for this Company
Contact
Feng Wang
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QZF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/14/2023
Decision Date
12/12/2023
Decision
DENG -
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
FDA Source Information for DEN230027
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