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Provox Activalve (size 4.5mm +4 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K092593

by Atos Medical AB

Identifiers

510(k) Number
K092593 FDA 510(k)
FDA Product Code
EWL FDA 510(k)
Models / Variants
size 4.5mm FDA 510(k)
6mm FDA 510(k)
8mm FDA 510(k)
10mm FDA 510(k)
12.5mm FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 874.3730 FDA 510(k)
Regulation Number
874.3730 FDA 510(k)
Advisory Committee
Ear, Nose, Throat FDA 510(k)
FDA Decision
SESK Substantially Equivalent — Kit FDA 510(k)

Provox Activalve (size 4.5mm +4 more) by Atos Medical AB — Class II — FDA_510K — listed in FDA 510(k) — 5 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Atos Medical AB

Sources (1)

  • FDA 510(k) K092593 24 fields · synced Jun 18, 2026