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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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101 to 110 of 416 results
Decision Date To: 06/01/2024
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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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GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY GIVEN IMAGING LTD. DEN120023 K123666 01/29/2014
AIRPURGE ANESTHESIA SAFETY PRODUCTS, LLC DEN080009 K080644 03/04/2014
CEFALY STX-MED SPRL DEN120019 K122566 03/11/2014
SIMPLEXA HSV 1&2 DIRECT FOCUS DIAGNOSTICS DEN130049 K133621 03/21/2014
IOGYN SYSTEM IOGYN, INC. DEN130040 K132695 03/28/2014
XSTAT REVMEDX, INC. DEN130016 K130218 04/03/2014
LYRA DIRECT STREP ASSAY QUIDEL CORPORATION DEN140005 K133883 04/16/2014
DEKA ARM SYSTEM DEKA INTEGRATED SOLUTIONS CORPORATION DEN120016 K121215 05/09/2014
PIXEL 3 SYSTEM GAUSS SURGICAL, INC. DEN130015 K130190 05/09/2014
QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASS DIAGNOSTIC HYBRIDS, INC. DEN140004 K133448 05/13/2014
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