Cleared Traditional

MITRAFLEX(TM) WOUND DRESSING

K873277 · Matrix Medica, Inc. · General & Plastic Surgery
Sep 1987
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K873277 is an FDA 510(k) clearance for the MITRAFLEX(TM) WOUND DRESSING, a Dressing, Wound, Occlusive (Class I — General Controls, product code NAD), submitted by Matrix Medica, Inc. (Wheat Ridge, US). The FDA issued a Cleared decision on September 17, 1987, 31 days after receiving the submission on August 17, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4020.

Submission Details

510(k) Number K873277 FDA.gov
FDA Decision Cleared SN
Date Received August 17, 1987
Decision Date September 17, 1987
Days to Decision 31 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code NAD — Dressing, Wound, Occlusive
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4020

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