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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: 05/22/2024
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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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PROSTATE MECHANICAL IMAGER ARTANN LABORATORIES, INC DEN100016 K093579 04/27/2012
PERCUTANEOUS SURGICAL SET WITH 5MM OR 10 ETHICON ENDO-SURGERY DEN110016 K110431 04/30/2012
PORTRAIT ANALYZER GREAT BASIN SCIENTIFIC DEN120013 K113358 04/30/2012
CDC DENV-1-4 REAL TIME RT-PCT ASSAY CENTERS FOR DISEASE CONTROL AND PREVENTI DEN120012 K113336 05/24/2012
NUCLEUS-X PTV CATHETER NUMED, INC. DEN080015 K082776 06/11/2012
VERIGENE GRAM POSITIVE BLOOD CULTURE NUC NANOSPHERE, INC DEN120014 K113450 06/26/2012
PROTEUS INGESTION CONFINMATION SYSTEMS PROTEUS BIOMEDICAL, INC. DEN120011 K113070 07/10/2012
VIRULITE COLD SORE MACHINE VIRULITE LLC DEN090012 K083767 10/18/2012
AHIP INTERNAL TRIGGER POINT WAND MODEL: NATIONAL CENTER FOR PELVIC PAIN RESEARCH DEN100023 K100934 11/20/2012
BIO-SEAL LUNG BIOPSY TRACT SYSTEM ANGIOTECH DEN090007 K082438 12/19/2012
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