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Gauze Sponge 12ply

FDA 510(k)

U (US FDA 510(k))

510(k) K882711

by Bioseal

Identifiers

510(k) Number
K882711 FDA 510(k)
FDA Product Code
EFQ FDA 510(k)

Classification

Device Class
U FDA 510(k)
Advisory Committee
Unknown FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Gauze Sponge 12ply by Bioseal — U — 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
Bioseal

Sources (1)

  • FDA 510(k) K882711 24 fields · synced Jun 19, 2026