FDA 510(k) Application Details - DEN230007

Device Classification Name

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510(K) Number DEN230007
Device Name LightStrike+ (MXSUV1-SL and MXSUV1-FT)
Applicant Xenex Disinfection Services, Inc.
1074 Arion Circle, Suite 116
San Antonio, TX 78254 US
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Contact Juan L. Gonzalez
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Regulation Number

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Classification Product Code QXJ
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Date Received 02/01/2023
Decision Date 09/01/2023
Decision DENG -
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status
Type Direct
Reviewed By Third Party N
Expedited Review



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