FDA 510(k) Application Details - K161484

Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes

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510(K) Number K161484
Device Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant ZIIP,LLC
1871 Trestle Glen Rd.,
Piedmont, CA 94610 US
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Contact David Mason
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Regulation Number 882.5890

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Classification Product Code NFO
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Date Received 05/31/2016
Decision Date 02/24/2017
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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