FDA 510(k) Application Details - K240188

Device Classification Name

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510(K) Number K240188
Device Name Vitruvian Liposaber
Applicant Black & Black Surgical, Inc.
5175 South Royal Atlanta Dr.
Tucker, GA 30084 US
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Contact Cynthia Rees
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Regulation Number

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Classification Product Code QPB
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Date Received 01/24/2024
Decision Date 09/13/2024
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

FDA Source Information for K240188


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