XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack— 510(k) K170334

Name: FDA 510(k) clearance K170334
Creator: U.S. Food and Drug Administration
Published: 2017-05-01

Substantially Equivalent

Revmedx, Inc.

FDA 510(k) clearance K170334 for XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack, Substantially Equivalent on 2017-05-01. 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: 2017-02-02
Decision date: 2017-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilsonville,, OR, US

Download summary PDF View on FDA.gov ↗

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