NPseal— 510(k) K200305

Substantially Equivalent

Guard Medical, Inc.

FDA 510(k) clearance K200305 for NPseal, Substantially Equivalent on 2020-05-26. 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: 2020-02-06
Decision date: 2020-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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More clearances from Guard Medical, Inc.

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