FDA 510(k) Application Details - K072260

Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes

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510(K) Number K072260
Device Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant Carol Cole Company
3366 N. TORREY PINES CT.
SUITE 130
LA JOLLA, CA 92037 US
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Contact HOWARD ASHER
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Regulation Number 882.5890

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Classification Product Code NFO
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Date Received 08/14/2007
Decision Date 11/27/2007
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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