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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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131 to 140 of 416 results
Decision Date To: 06/16/2024
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Device Name
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De Novo
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510(k)
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Decision
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Plenity Gelesis, Inc. DEN180060 04/12/2019
PIXEL 3 SYSTEM GAUSS SURGICAL, INC. DEN130015 K130190 05/09/2014
Pill Sense System EnteraSense Ltd. DEN220065 02/24/2023
picoAMH ELISA Ansh Labs LLC DEN180004 10/24/2018
Philips IntelliSite Pathology Solution Philips Medical Systems Nederland B.V. DEN160056 04/12/2017
PHICAL TEST GENOVA DIAGNOSTICS DEN060001 K050007 04/26/2006
Phagenyx System Phagenesis Limited DEN220025 09/16/2022
Permaseal MICRO INTERVENTIONAL DEVICES, INC. DEN150029 07/27/2016
PERKINELMER ENLITE NEONATAL TREC TEST SY WALLAC OY DEN140010 12/15/2014
PERCUTANEOUS SURGICAL SET WITH 5MM OR 10 ETHICON ENDO-SURGERY DEN110016 K110431 04/30/2012
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