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De Novo DXE

Device
Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   Device Classification Under Section 513(f)(2)(de Novo) Var MP = { Version: '1.0.22', Domains: {'es':'esp.fd
Requester
Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Fo
Requester address
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Contact
Device Classification Under Section 513(f)(2)(de N
De Novo number
DXE
510(k) number
DEVICECLASSIFICATIONUNDERSECTION513F2DENOVOQUICKLINKSSKIPTOMAINPAGECONTENTSKIPTOSEARCHSKIPTOTOPICSMENUSKIPTOCOMMONLIN
Product code
DEVICE CLASSIFICATION UNDER SECTION 513(F)(2)(DE NOVO) // QUICK LINKS: SKIP TO MAIN PAGE CONTENT SKI
Regulation
Device Classification Under Section 513(f)(2)(de N
Classification name
Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food &amp; Drug Administration &nbsp; Follow FDA En Espa&ntilde;ol Search FDA &nbsp; Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood &amp; Biologics Animal &amp; Veterinary Cosmetics Tobacco Products &nbsp; Device Classification Under Section 513(f)(2)(de Novo) Var MP = { Version: '1.0.22', Domains: {'es':'esp.fd
Decision
Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food &amp; Drug Administration &nbsp; Follow FDA En Espa&ntilde;ol Search FDA &nbsp; Home Fo
Classification advisory
Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food &amp; Drug Administration &nbsp; Follow FDA En Espa&ntilde;ol Search FDA &nbsp; Home Fo
Review advisory
Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food &amp; Drug Administration &nbsp; Follow FDA En Espa&ntilde;ol Search FDA &nbsp; Home Fo
Type
Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food &amp; Drug Administration &nbsp; Follow FDA En Espa&ntilde;ol Search FDA &nbsp; Home Fo