FDA 510(k) Application Details - K161849

Device Classification Name Light Based Over The Counter Wrinkle Reduction

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510(K) Number K161849
Device Name Light Based Over The Counter Wrinkle Reduction
Applicant Tanda Beauty Canada Inc.
11-380 Jamieson Parkway
Cambridge CA
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Contact Bobae Kim
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Regulation Number 878.4810

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Classification Product Code OHS
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Date Received 07/05/2016
Decision Date 07/29/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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