Cleared Traditional

ENVISAN PAD

K874552 · Marion Laboratories, Inc. · General & Plastic Surgery
Jan 1988
Decision
79d
Days
Class 1
Risk

About This 510(k) Submission

K874552 is an FDA 510(k) clearance for the ENVISAN PAD, a Beads, Hydrophilic, For Wound Exudate Absorption (Class I — General Controls, product code KOZ), submitted by Marion Laboratories, Inc. (Kansas City, US). The FDA issued a Cleared decision on January 22, 1988, 79 days after receiving the submission on November 4, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4018.

Submission Details

510(k) Number K874552 FDA.gov
FDA Decision Cleared SN
Date Received November 04, 1987
Decision Date January 22, 1988
Days to Decision 79 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code KOZ — Beads, Hydrophilic, For Wound Exudate Absorption
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4018

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