FDA 510(k) Application Details - K131251

Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes

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510(K) Number K131251
Device Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant Carol Cole Company
1325 Sycamore Ave Ste A
Vista, CA 92081 US
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Contact Rand Daoud
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Regulation Number 882.5890

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Classification Product Code NFO
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Date Received 05/01/2013
Decision Date 10/01/2013
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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