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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: 05/17/2024
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Device Name
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Requester
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De Novo
Number
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510(k)
Number
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Decision
Date
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APTUS STEERABLE ENDOGUIDE WITH OBTURATOR APTUS ENDOSYSTEMS, INC. DEN100026 K102333 11/21/2011
RIDASCREEN NOROVIRUS 3RD GENERATION EIA R-Biopharm AG DEN110001 K093295 02/23/2011
SYSTEM 1E PROCESS BIOLOGICAL MONITORING STERIS Corporation DEN110002 K100049 03/30/2012
CABOCHON SYSTEM CABOCHON AESTHETICS, INC. DEN110004 K101231 07/12/2013
VERIFY CRONOS SELF-CONTAINED BIOLOGICAL STERIS Corporation DEN110006 K102469 07/12/2013
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
APTIMA TRICHOMONAS VAGINALIS ASSAY GEN-PROBE INCORPORATED DEN110012 K102911 04/19/2011
PERCUTANEOUS SURGICAL SET WITH 5MM OR 10 ETHICON ENDO-SURGERY DEN110016 K110431 04/30/2012
NEBA SYSTEM LEXICOR MEDICAL TECHNOLOGY, LLC DEN110019 K112711 07/15/2013
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