NPseal— 510(k) K250708

Substantially Equivalent

Guard Medical, Inc.

FDA 510(k) clearance K250708 for NPseal, Substantially Equivalent on 2025-04-08. 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: 2025-03-10
Decision date: 2025-04-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Guard Medical, Inc.

K200305 — NPseal2020-05-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.