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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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61 to 70 of 415 results
Decision Date To: 05/23/2024
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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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Cala ONE Cala Health, Inc. DEN170028 04/26/2018
Canary Tibial Extension with Canary Heal Canary Medical, Inc. DEN200064 08/27/2021
Caption Guidance Bay Labs, Inc. DEN190040 02/07/2020
Caption Interpretation Automated Ejectio Caption Health, Inc DEN220063 02/24/2023
CARDIOMEMS ENDOSENSOR WITH DELIVERY SYST CARDIOMEMS INC DEN050006 K050939 10/28/2005
CARPEDIEM System Bellco srl (now part of Medtronic, Inc) DEN180055 04/29/2020
CavaClear Laser Sheath Spectranetics, Inc. DEN210024 12/21/2021
CDC DENV-1-4 REAL TIME RT-PCT ASSAY CENTERS FOR DISEASE CONTROL AND PREVENTI DEN120012 K113336 05/24/2012
CEDIA SIROLIMUS ASSAY MICROGENICS CORP. DEN040008 K034069 07/28/2004
CEFALY STX-MED SPRL DEN120019 K122566 03/11/2014
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