FDA 510(k) Application Details - K222770

Device Classification Name Media, Electroconductive

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510(K) Number K222770
Device Name Media, Electroconductive
Applicant Top-Rank Health Care Co.,Ltd.
Mashan Village, Dongguan Street, Shangyu District
Shaoxing 312300 CN
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Contact Gangfeng Lou
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Regulation Number 882.1275

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Classification Product Code GYB
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Date Received 09/14/2022
Decision Date 12/13/2022
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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