Cleared Traditional

HEMO-Bandage

K151204 · Coreleader Biotech Co., Ltd. · General & Plastic Surgery
Jul 2015
Decision
87d
Days
—
Risk

About This 510(k) Submission

K151204 is an FDA 510(k) clearance for the HEMO-Bandage, a Hemostatic Wound Dressing Without Thrombin Or Other Biologics, submitted by Coreleader Biotech Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on July 31, 2015, 87 days after receiving the submission on May 5, 2015. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K151204 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2015
Decision Date July 31, 2015
Days to Decision 87 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code QSY — Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class —
Definition To Temporarily Control Bleeding And Cover External Wounds.

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