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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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91 to 100 of 416 results
Decision Date To: 06/16/2024
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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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VITEK MS BIOMERIEUX, INC. DEN130013 K124067 08/21/2013
UROLIFT SYSTEM NEOTRACT, INC. DEN130023 K130651 09/13/2013
ILLUMINA MISEQDX PLATFORM ILLUMINA, INC. DEN130011 K123989 11/19/2013
MISEQDX UNIVERSAL KIT 1.0 ILLUMINA, INC. DEN130042 K133136 11/19/2013
NEURALIEVE CERENA TRANSCRANIAL MAGNETIC ENEURA THERAPEUTICS DEN130022 K130556 12/13/2013
RESTLESS LEG DEVICE MARY M. SORG (AN INDIVIDUAL) DBA PJ SLEE DEN110009 K102707 12/18/2013
SYMPHONY DEVICE SENSORY MEDICAL, INC DEN110011 K102873 12/18/2013
AXIOS STENT AND DELIVERY SYSTEM XLUMENA, INC DEN130007 K123250 12/18/2013
CYTOSCAN(R) DX Affymetrix, Inc. DEN130018 K130313 01/17/2014
PROSTATE IMMOBILIZER RECTAL BALLOON RADIADYNE DEN130036 K132194 01/28/2014
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