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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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31 to 40 of 416 results
Decision Date To: 05/31/2024
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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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ULTHERA SYSTEM, MODEL 8850-0001 ULTHERA, INC. DEN080006 K072505 09/11/2009
everlinQ endoAVF System TVA Medical, Inc. DEN160006 06/22/2018
Tristel Duo ULT Tristel Solutions Limited DEN220041 06/02/2023
Tornier Pyrocarbon Humeral Head Tornier SAS DEN220012 12/16/2022
TAG-IT CYSTIC FIBROSIS KIT TM BIOSCIENCE CORPORATION DEN050004 K043011 05/09/2005
ClearUP Sinus Relief Tivic Health Systems Inc. DEN200006 03/05/2021
Enlight 1810 Timpel Inc. DEN170072 12/20/2018
ClearMate Thornhill Research, Inc. DEN170044 03/14/2019
Nerivio Migra Theranica Bioelectronics ltd DEN180059 05/20/2019
TEPHAFLEX ABSORBABLE SUTURE TEPHA, INC. DEN060003 K052225 02/08/2007
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