Invictus Medical GelShield— 510(k) K150243

Name: FDA 510(k) clearance K150243
Creator: U.S. Food and Drug Administration
Published: 2015-05-01

Substantially Equivalent

Invictus Medical, Inc.

FDA 510(k) clearance K150243 for Invictus Medical GelShield, Substantially Equivalent on 2015-05-01. Applicant: Invictus Medical, Inc.. Device class: 1.

Clearance details

Applicant: Invictus Medical, Inc.
Product code: Code FMP
Device class: Class 1
Regulation: 21 CFR 880.6450
Advisory panel: General Hospital
Date received: 2015-02-02
Decision date: 2015-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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