FDA 510(k) Application Details - K232749

Device Classification Name

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510(K) Number K232749
Device Name DOOPANG
Applicant Ybrain, Inc.
#202, 2 floor, 71, Jukdong-ro, Yuseong-gu
Daejeon 34127 KR
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Contact Kiwon Lee
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Regulation Number

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Classification Product Code PCC
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Date Received 09/08/2023
Decision Date 06/11/2024
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

FDA Source Information for K232749


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