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Irrigation Tray W/ Bulb Syringe

FDA 510(k)

Class I (US FDA 510(k))

510(k) K924809

by Customed, Inc.

Identifiers

510(k) Number
K924809 FDA 510(k)
FDA Product Code
KYZ FDA 510(k)

Classification

Device Class
Class I FDA 510(k)
Legislation / Framework
21 CFR Part 880.6960 FDA 510(k)
Regulation Number
880.6960 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SEKD FDA 510(k)

Irrigation Tray W/ Bulb Syringe by Customed, Inc. — Class I — 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
Customed, Inc.

Sources (1)

  • FDA 510(k) K924809 24 fields · synced Jun 18, 2026