FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE— 510(k) K122330

Name: FDA 510(k) clearance K122330
Creator: U.S. Food and Drug Administration
Published: 2012-12-07

Substantially Equivalent

Arjohuntleigh Polska SP Z.O.O.

FDA 510(k) clearance K122330 for FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE, Substantially Equivalent on 2012-12-07. Applicant: Arjohuntleigh Polska SP Z.O.O.. Device class: 2.

Clearance details

Applicant: Arjohuntleigh Polska SP Z.O.O.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2012-08-02
Decision date: 2012-12-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Cardiff, GB

Download summary PDF View on FDA.gov ↗

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