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Urethane Picc Line Model Upics-

FDA 510(k)

Class II (US FDA 510(k))

510(k) K992198

by Cook, Inc.

Identifiers

510(k) Number
K992198 FDA 510(k)
FDA Product Code
FOZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5200 FDA 510(k)
Regulation Number
880.5200 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Urethane Picc Line Model Upics- by Cook, Inc. — 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
Cook, Inc.

Sources (1)

  • FDA 510(k) K992198 24 fields · synced Jun 18, 2026