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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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21 to 30 of 413 results
Decision Date To: 05/15/2024
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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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RELIZORB ALCRESTA, INC. DEN150001 11/20/2015
WOUNDCHEK Bacterial Status Alere Scarborough, Inc. DEN180014 12/02/2019
Ultravision Visual Clearing System Alesi Surgical Ltd. DEN150022 12/20/2016
TrueTear Intranasal Tear Neurostimulator Allergan DEN170086 05/17/2018
Hemolung Respiratory Assist System ALung Technologies, Inc. DEN210006 11/13/2021
Parsortix PC1 Device ANGLE Europe Ltd. DEN200062 05/24/2022
NaviCam ProScan Ankon Technologies Co., Ltd DEN230027 12/12/2023
picoAMH ELISA Ansh Labs LLC DEN180004 10/24/2018
NaviCam Capsule Endoscope System with Na AnX Robotica, Inc. DEN190037 05/22/2020
APOLLO ESG System, APOLLO ESG SX System, Apollo Endosurgery, Inc. DEN210045 07/12/2022
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