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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Decision Date To: 05/23/2024
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Download Files | More About De Novo
Device Name
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Requester
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De Novo
Number
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510(k)
Number
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Decision
Date
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ERCHONIA ML SCANNER (MLS) ERCHONIA MEDICAL DEN090008 K082609 08/24/2010
BIO-SEAL LUNG BIOPSY TRACT SYSTEM ANGIOTECH DEN090007 K082438 12/19/2012
PRINEO SKIN CLOSURE SYSTEM CLOSURE MEDICAL CORP. DEN090005 K082289 04/30/2010
OVA1 TEST VERMILLION DEN090004 K081754 09/11/2009
SNAP WOUND CARE DEVICE SPIRACUR, INC. DEN080011 K081406 08/07/2009
AIRPURGE ANESTHESIA SAFETY PRODUCTS, LLC DEN080009 K080644 03/04/2014
ZELTIQ AESTHETICS DERMAL COOLING DEVICE ZELTIQ AESTHETICS DEN090002 K080521 08/24/2010
INFRASCANNER, MODEL 1000 INFRASCAN, INC. DEN100002 K080377 12/13/2011
ALLOMAP MOLECULAR EXPRESSION TESTING XDX DEN080007 K073482 08/26/2008
ULTHERA SYSTEM, MODEL 8850-0001 ULTHERA, INC. DEN080006 K072505 09/11/2009
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