Cleared Traditional

BIOCLUSIVE(R) ABSORBENT DRESSING

K896828 · Johnson & Johnson International · General & Plastic Surgery
Nov 1990
Decision
352d
Days
Class 1
Risk

About This 510(k) Submission

K896828 is an FDA 510(k) clearance for the BIOCLUSIVE(R) ABSORBENT DRESSING, a Beads, Hydrophilic, For Wound Exudate Absorption (Class I — General Controls, product code KOZ), submitted by Johnson & Johnson International (New Brunswick, US). The FDA issued a Cleared decision on November 21, 1990, 352 days after receiving the submission on December 4, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4018.

Submission Details

510(k) Number K896828 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 1989
Decision Date November 21, 1990
Days to Decision 352 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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