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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: 05/11/2024
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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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HEM-AVERT PERIANAL STABILIZER PLEXUS BIOMEDICAL INC. DEN090011 K083692 01/13/2011
VIRULITE COLD SORE MACHINE VIRULITE LLC DEN090012 K083767 10/18/2012
INFRASCANNER, MODEL 1000 INFRASCAN, INC. DEN100002 K080377 12/13/2011
VIOGUARD SELF-SANITIZING KEYBOARD, MODEL VIOGUARD DEN100013 K092996 12/20/2011
PROSTATE MECHANICAL IMAGER ARTANN LABORATORIES, INC DEN100016 K093579 04/27/2012
LIPFLOW THERMAL PULSATION SYSTEM (FORMER TEARSCIENCE, INC. DEN100017 K093937 06/28/2011
DENV DETECT IGM CAPTURE ELISA INBIOS INTL., INC. DEN100020 K100534 04/08/2011
AHIP INTERNAL TRIGGER POINT WAND MODEL: NATIONAL CENTER FOR PELVIC PAIN RESEARCH DEN100023 K100934 11/20/2012
ZAP-IT! ECOBRANDS LTD. DEN100024 11/07/2014
WIDEXLINK IN CLEAR SERIES HEARING AIDS OFFICE RESEARCH IN CLINICAL AMPLIFICTION DEN100025 K101699 03/31/2011
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