NPseal (Small, Medium, Large)— 510(k) K240244

Name: FDA 510(k) clearance K240244
Creator: U.S. Food and Drug Administration
Published: 2024-02-29

Substantially Equivalent

Guard Medical, Inc.

FDA 510(k) clearance K240244 for NPseal (Small, Medium, Large), Substantially Equivalent on 2024-02-29. Applicant: Guard Medical, Inc.. Device class: 2.

Clearance details

Applicant: Guard Medical, Inc.
Product code: Code OKO
Device class: Class 2
Regulation: 21 CFR 878.4683
Advisory panel: General, Plastic Surgery
Date received: 2024-01-30
Decision date: 2024-02-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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