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FDA 510(k) Application Details - K222735
Device Classification Name
Endoscope, Neurological
More FDA Info for this Device
510(K) Number
K222735
Device Name
Endoscope, Neurological
Applicant
HJY Smart Medical Device Co., Ltd.
12F., No. 415, Sec. 4, Xinyi Dist.
Taipei City 11051 TW
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Contact
John Jiannyuh Chen
Other 510(k) Applications for this Contact
Regulation Number
882.1480
More FDA Info for this Regulation Number
Classification Product Code
GWG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/09/2022
Decision Date
07/28/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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