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Piezoelectric System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K100410

by Satelec

Identifiers

510(k) Number
K100410 FDA 510(k)
FDA Product Code
JDX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.4580 FDA 510(k)
Regulation Number
888.4580 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Piezoelectric System by Satelec — 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
Satelec

Sources (1)

  • FDA 510(k) K100410 24 fields · synced Jun 19, 2026