FDA 510(k) Application Details - K233095

Device Classification Name Stimulator, Nerve, Transcutaneous, Over-The-Counter

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510(K) Number K233095
Device Name Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant Micro Current Technology, Inc.
2244 1st Ave. South
Seattle, WA 98134 US
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Contact David Suzuki
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Regulation Number 882.5890

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Classification Product Code NUH
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Date Received 09/26/2023
Decision Date 03/01/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K233095


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