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NPseal - Small

FDA 510(k)

Class II (US FDA 510(k))

510(k) K240244

by Guard Medical, Inc.

Identifiers

510(k) Number
K240244 FDA 510(k)
FDA Product Code
OKO FDA 510(k)
Models / Variants
Small FDA 510(k)
Medium FDA 510(k)
Large FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4683 FDA 510(k)
Regulation Number
878.4683 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

NPseal - Small by Guard Medical, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 3 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Guard Medical, Inc.

Sources (1)

  • FDA 510(k) K240244 24 fields · synced Jun 18, 2026