Cleared Traditional

LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING

K140954 · Huizhou Foryou Medical Devices Co., Ltd. · General & Plastic Surgery
Mar 2015
Decision
343d
Days
Risk

About This 510(k) Submission

K140954 is an FDA 510(k) clearance for the LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING, a Dressing, Wound, Drug, submitted by Huizhou Foryou Medical Devices Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on March 23, 2015, 343 days after receiving the submission on April 14, 2014. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K140954 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2014
Decision Date March 23, 2015
Days to Decision 343 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FRO — Dressing, Wound, Drug
Device Class

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