Cleared Traditional

K022854 - ACELL UBM HYDRATED WOUND DRESSING (FDA 510(k) Clearance)

K022854 · Acell, Inc. · General & Plastic Surgery device

Dec 2002

Decision

137d

Days

—

Risk

K022854 is an FDA 510(k) clearance for the ACELL UBM HYDRATED WOUND DRESSING. This device is classified as a Wound Dressing With Animal-derived Material(s).

Submitted by Acell, Inc. (Washington, US). The FDA issued a Cleared decision on December 30, 2002, 137 days after receiving the submission on August 15, 2002.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number	K022854 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 15, 2002
Decision Date	December 30, 2002
Days to Decision	137 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF