COMPRESSIBLE LIMB SLEEVE SYSTEM— 510(k) K130385

Name: FDA 510(k) clearance K130385
Creator: U.S. Food and Drug Administration
Published: 2014-02-18

Substantially Equivalent

Maxstar Industrial Co., Ltd.

FDA 510(k) clearance K130385 for COMPRESSIBLE LIMB SLEEVE SYSTEM, Substantially Equivalent on 2014-02-18. Applicant: Maxstar Industrial Co., Ltd.. Device class: 2.

Clearance details

Applicant: Maxstar Industrial Co., Ltd.
Product code: Code IRP
Device class: Class 2
Regulation: 21 CFR 890.5650
Advisory panel: Physical Medicine
Date received: 2013-02-15
Decision date: 2014-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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