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Flow-Nail

FDA 510(k)

Class II (US FDA 510(k))

510(k) K140601

by Flow-Fx, LLC

Identifiers

510(k) Number
K140601 FDA 510(k)
FDA Product Code
HSB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3020 FDA 510(k)
Regulation Number
888.3020 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Flow-Nail by Flow-Fx, LLC — 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
Flow-Fx, LLC

Sources (1)

  • FDA 510(k) K140601 24 fields · synced Jun 19, 2026