Cleared Traditional

LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM

K120181 · Huizhou Foryou Medical Devices Co., Ltd. · General & Plastic Surgery
Feb 2013
Decision
391d
Days
Risk

About This 510(k) Submission

K120181 is an FDA 510(k) clearance for the LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM, a Dressing, Wound, Drug, submitted by Huizhou Foryou Medical Devices Co., Ltd. (Pennington, US). The FDA issued a Cleared decision on February 14, 2013, 391 days after receiving the submission on January 20, 2012. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K120181 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 2012
Decision Date February 14, 2013
Days to Decision 391 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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