FDA 510(k) Application Details - K230506

Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes

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510(K) Number K230506
Device Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant Xtreem Pulse
353 W. 29th St., Suite 3
New York, NY 10001 US
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Contact Andrew Barile
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Regulation Number 882.5890

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Classification Product Code NFO
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Date Received 02/24/2023
Decision Date 06/21/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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