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Body Band Restraint Strap Set

FDA 510(k)

Class II (US FDA 510(k))

510(k) K923107

by Cook, Inc.

Identifiers

510(k) Number
K923107 FDA 510(k)
FDA Product Code
JAA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1650 FDA 510(k)
Regulation Number
892.1650 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Body Band Restraint Strap Set 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) K923107 24 fields · synced Jun 18, 2026