FDA 510(k) Application Details - K201475

Device Classification Name

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510(K) Number K201475
Device Name Ultimate Contour, Ultimate Contour Mini
Applicant CAO Group, Inc.
4628 West Skyhawk Drive
West Jordan, UT 84084 US
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Contact Robert K. Larsen
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Regulation Number

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Classification Product Code PBX
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Date Received 06/03/2020
Decision Date 10/28/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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