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Ace Medical Surgical Instruments

FDA 510(k)

Class II (US FDA 510(k))

510(k) K200387

by Ace Medical

Identifiers

510(k) Number
K200387 FDA 510(k)
FDA Product Code
HAE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4840 FDA 510(k)
Regulation Number
882.4840 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Ace Medical Surgical Instruments by Ace Medical — 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
Ace Medical

Sources (1)

  • FDA 510(k) K200387 24 fields · synced Jun 18, 2026