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Disposable Syringe (Kit) +1 more model

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242212

by Nemoto Kyorindo Co., Ltd.

Identifiers

510(k) Number
K242212 FDA 510(k)
FDA Product Code
DXT FDA 510(k)
Models / Variants

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1650 FDA 510(k)
Regulation Number
870.1650 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Disposable Syringe (Kit) +1 more model by Nemoto Kyorindo Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 2 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Sources (1)

  • FDA 510(k) K242212 24 fields · synced Jun 18, 2026