Cleared Traditional

CALGITROL AG SILVER ALGINATE WOUND DRESSING

K011618 · Adri · General & Plastic Surgery
Nov 2002
Decision
539d
Days
—
Risk

About This 510(k) Submission

K011618 is an FDA 510(k) clearance for the CALGITROL AG SILVER ALGINATE WOUND DRESSING, a Dressing, Wound, Drug, submitted by Adri (Park Forest, US). The FDA issued a Cleared decision on November 15, 2002, 539 days after receiving the submission on May 25, 2001. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K011618 FDA.gov
FDA Decision Cleared SESE
Date Received May 25, 2001
Decision Date November 15, 2002
Days to Decision 539 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code FRO — Dressing, Wound, Drug
Device Class —

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