FDA 510(k) Application Details - K201680

Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes

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510(K) Number K201680
Device Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant Carole Cole Company
1325 Sycamore Ave, Suite A
Vista, CA 92081 US
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Contact Danielle Barker Fernandes
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Regulation Number 882.5890

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Classification Product Code NFO
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Date Received 06/22/2020
Decision Date 02/19/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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