← Back to catalogue

Tegapore Wound Contact Material, Product #563x

FDA 510(k)

Class I (US FDA 510(k))

510(k) K890354

by 3m Company

Identifiers

510(k) Number
K890354 FDA 510(k)
FDA Product Code
NAD FDA 510(k)

Classification

Device Class
Class I FDA 510(k)
Legislation / Framework
21 CFR Part 878.4020 FDA 510(k)
Regulation Number
878.4020 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SN FDA 510(k)

Tegapore Wound Contact Material, Product #563x by 3m Company — Class I — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
3m Company

Sources (1)

  • FDA 510(k) K890354 24 fields · synced Jun 18, 2026