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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: 06/15/2024
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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)
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Decision
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QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE D QUICK-MED TECHNOLOGIES, INC. DEN070002 K060662 02/25/2009
SNAP WOUND CARE DEVICE SPIRACUR, INC. DEN080011 K081406 08/07/2009
ULTHERA SYSTEM, MODEL 8850-0001 ULTHERA, INC. DEN080006 K072505 09/11/2009
OVA1 TEST VERMILLION DEN090004 K081754 09/11/2009
PRINEO SKIN CLOSURE SYSTEM CLOSURE MEDICAL CORP. DEN090005 K082289 04/30/2010
ERCHONIA ML SCANNER (MLS) ERCHONIA MEDICAL DEN090008 K082609 08/24/2010
ZELTIQ AESTHETICS DERMAL COOLING DEVICE ZELTIQ AESTHETICS DEN090002 K080521 08/24/2010
HEM-AVERT PERIANAL STABILIZER PLEXUS BIOMEDICAL INC. DEN090011 K083692 01/13/2011
RIDASCREEN NOROVIRUS 3RD GENERATION EIA R-Biopharm AG DEN110001 K093295 02/23/2011
MANDOMETER III AB MANDO DEN070014 K063817 03/31/2011
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