FDA 510(k) Application Details - K220592

Device Classification Name

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510(K) Number K220592
Device Name Venus BlissMAX
Applicant Venus Concept USA Inc.
1880 N Commerce Pkwy, Suite 2
Weston, FL 33326 US
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Contact William H. McGrail
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Regulation Number

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Classification Product Code PBX
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Date Received 03/01/2022
Decision Date 04/27/2022
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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