Cleared Special

EXCELARREST FOAM

K072900 · Hemostasis, LLC · General & Plastic Surgery
Oct 2007
Decision
15d
Days
—
Risk

About This 510(k) Submission

K072900 is an FDA 510(k) clearance for the EXCELARREST FOAM, a Hemostatic Wound Dressing Without Thrombin Or Other Biologics, submitted by Hemostasis, LLC (St. Paul, US). The FDA issued a Cleared decision on October 26, 2007, 15 days after receiving the submission on October 11, 2007. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K072900 FDA.gov
FDA Decision Cleared SESE
Date Received October 11, 2007
Decision Date October 26, 2007
Days to Decision 15 days
Submission Type Special
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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