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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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141 to 150 of 416 results
Decision Date To: 06/01/2024
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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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RELIZORB ALCRESTA, INC. DEN150001 11/20/2015
Dignitana AB DigniCap System DIGNITANA AB DEN150010 12/08/2015
Newa Skin Therapy System EndyMed Medical Ltd. DEN150005 12/18/2015
cNEP Airway Sommetrics DEN140024 12/23/2015
B.R.A.H.M.S PCT sensitive KRYPTOR B.R.A.H.M.S GMBH DEN150009 02/20/2016
SENSIMED TRIGGERFISH SENSIMED AG DEN140017 03/04/2016
Amplichek II, Negative and Amplichek II, Bio-Rad Laboratories DEN150058 03/28/2016
PneumoLiner ADVANCED SURGICAL CONCEPTS LTD. DEN150028 04/07/2016
GLAUCOMA COMPANION INNOVATEX, INC. DEN140022 04/20/2016
KRONUS Aquaporin-4 Autoantibody (AQP4Ab) KRONUS, INC. DEN150030 04/25/2016
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