Cleared Traditional

POSISEP AND POSISEP X HEMOSTAT DRESSINGS

K120958 · Hemostasis, LLC · General & Plastic Surgery
Jul 2012
Decision
117d
Days
—
Risk

About This 510(k) Submission

K120958 is an FDA 510(k) clearance for the POSISEP AND POSISEP X HEMOSTAT DRESSINGS, a Hemostatic Wound Dressing Without Thrombin Or Other Biologics, submitted by Hemostasis, LLC (St. Paul, US). The FDA issued a Cleared decision on July 25, 2012, 117 days after receiving the submission on March 30, 2012. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K120958 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2012
Decision Date July 25, 2012
Days to Decision 117 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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