RESTORE MODULAR STERILIZATION TRAY SYSTEM— 510(k) K131455

Name: FDA 510(k) clearance K131455
Creator: U.S. Food and Drug Administration
Published: 2013-08-30

Substantially Equivalent

Restore Medical Solutions, Inc.

FDA 510(k) clearance K131455 for RESTORE MODULAR STERILIZATION TRAY SYSTEM, Substantially Equivalent on 2013-08-30. Applicant: Restore Medical Solutions, Inc.. Device class: 2.

Clearance details

Applicant: Restore Medical Solutions, Inc.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2013-05-20
Decision date: 2013-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chevy Chase, MD, US

Download summary PDF View on FDA.gov ↗

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