Cleared Traditional

CURAGEL HYDROGEL WOUND DRESSING

K950412 · Kendall Healthcare Products Co. Div.Of Tyco Health · General & Plastic Surgery
Mar 1995
Decision
52d
Days
Class 1
Risk

About This 510(k) Submission

K950412 is an FDA 510(k) clearance for the CURAGEL HYDROGEL WOUND DRESSING, a Dressing, Wound, Hydrogel Without Drug And/or Biologic (Class I — General Controls, product code NAE), submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on March 24, 1995, 52 days after receiving the submission on January 31, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4022.

Submission Details

510(k) Number K950412 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 1995
Decision Date March 24, 1995
Days to Decision 52 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code NAE — Dressing, Wound, Hydrogel Without Drug And/or Biologic
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4022

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