FDA 510(k) Application Details - K243749

Device Classification Name Media, Electroconductive

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510(K) Number K243749
Device Name Media, Electroconductive
Applicant Shenzhen Ulike Smart Electronics Co., Ltd.
810, Building 1, Xunmei Science and Technology Plaza
No. 8 Keyuan Road, Science Park Community
Shenzhen CN
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Contact Yang Blue
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Regulation Number 882.1275

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Classification Product Code GYB
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Date Received 12/05/2024
Decision Date 04/08/2025
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 K243749


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