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Dukal Skin Closure Strip

FDA 510(k)

Class I (US FDA 510(k))

510(k) K931005

by Dukal Corp.

Identifiers

510(k) Number
K931005 FDA 510(k)
FDA Product Code
FPX FDA 510(k)

Classification

Device Class
Class I FDA 510(k)
Legislation / Framework
21 CFR Part 880.5240 FDA 510(k)
Regulation Number
880.5240 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Dukal Skin Closure Strip by Dukal Corp. — 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
Dukal Corp.

Sources (1)

  • FDA 510(k) K931005 24 fields · synced Jun 19, 2026