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Etex Mixing And Delivery System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K141245

by Etex Corporation

Identifiers

510(k) Number
K141245 FDA 510(k)
FDA Product Code
FMF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5860 FDA 510(k)
Regulation Number
880.5860 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Etex Mixing And Delivery System by Etex Corporation — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Etex Corporation

Sources (1)

  • FDA 510(k) K141245 24 fields · synced Jun 18, 2026