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Unigraft

FDA 510(k)

Class II (US FDA 510(k))

510(k) K993784

by Unicare Biomedical

Identifiers

510(k) Number
K993784 FDA 510(k)
FDA Product Code
LYC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3930 FDA 510(k)
Regulation Number
872.3930 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Unigraft by Unicare Biomedical — 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
Unicare Biomedical

Sources (1)

  • FDA 510(k) K993784 24 fields · synced Jun 18, 2026