Cleared Traditional

ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES

K893123 · Les Laboratorires Brothier, S.A. · General & Plastic Surgery
Feb 1990
Decision
294d
Days
—
Risk

About This 510(k) Submission

K893123 is an FDA 510(k) clearance for the ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES, a Hemostatic Wound Dressing Without Thrombin Or Other Biologics, submitted by Les Laboratorires Brothier, S.A. (Arlington, US). The FDA issued a Cleared decision on February 13, 1990, 294 days after receiving the submission on April 25, 1989. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K893123 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 1989
Decision Date February 13, 1990
Days to Decision 294 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

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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