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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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211 to 220 of 412 results
Decision Date To: 05/03/2024
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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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Precision Flow® HVNI VAPOTHERM, INC. DEN170001 04/10/2018
IDx-DR IDx, LLC DEN180001 04/11/2018
MALDI Biotyper CA System Bruker Daltonik GmbH DEN170081 04/20/2018
LZI Carisoprodol Metabolite (Meprobamate Lin-Zhi International, Inc. DEN170010 04/20/2018
Cala ONE Cala Health, Inc. DEN170028 04/26/2018
Hemospray Endoscopic Hemostat Wilson-Cook Medical, Inc DEN170015 05/07/2018
TrueTear Intranasal Tear Neurostimulator Allergan DEN170086 05/17/2018
OsteoDetect Imagen Technologies, Inc. DEN180005 05/24/2018
Curve Positive Airway Pressure System FRESCA Medical DEN170089 06/05/2018
DreaMed Advisor Pro DreaMed Diabetes, Ltd. DEN170043 06/12/2018
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