XSTAT 30, 3-PACK, XSTAT 30, 1-PACK— 510(k) K152624

Name: FDA 510(k) clearance K152624
Creator: U.S. Food and Drug Administration
Published: 2015-12-07

Substantially Equivalent

Revmedx, Inc.

FDA 510(k) clearance K152624 for XSTAT 30, 3-PACK, XSTAT 30, 1-PACK, Substantially Equivalent on 2015-12-07. Applicant: Revmedx, Inc.. Device class: 2.

Clearance details

Applicant: Revmedx, Inc.
Product code: Code PGZ
Device class: Class 2
Regulation: 21 CFR 878.4452
Advisory panel: General, Plastic Surgery
Date received: 2015-09-14
Decision date: 2015-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilsonville,, OR, US

Download summary PDF View on FDA.gov ↗

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