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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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51 to 60 of 412 results
Decision Date To: 05/01/2024
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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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THE 3PM EGG MACHINE 3PM CO., INC. DEN990005 K984637 08/20/1999
TEPHAFLEX ABSORBABLE SUTURE TEPHA, INC. DEN060003 K052225 02/08/2007
Technozym ADAMTS13 Activity Technoclone Herstellung von Diagnostika DEN230024 02/28/2024
Tangible Boost Tangible Science, Inc. DEN200002 09/24/2020
TAG-IT CYSTIC FIBROSIS KIT TM BIOSCIENCE CORPORATION DEN050004 K043011 05/09/2005
T2CANDIDA AND T2DX INSTRUMENT T2 BIOSYSTEMS, INC DEN140019 09/22/2014
t:slim X2 insulin pump with interoperabl Tandem Diabetes Care, Inc. DEN180058 02/14/2019
SYSTEM 1E PROCESS BIOLOGICAL MONITORING STERIS Corporation DEN110002 K100049 03/30/2012
Synovasure Alpha Defensin Lateral Flow T CD Diagnostics Inc. DEN180032 05/23/2019
SYMPHONY DEVICE SENSORY MEDICAL, INC DEN110011 K102873 12/18/2013
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