Cleared Special

K061711 - OASIS WOUND MATRIX
(FDA 510(k) Clearance)

K061711 · Cook Biotech, Inc. · General & Plastic Surgery

Jul 2006

Decision

30d

Days

—

Risk

K061711 is an FDA 510(k) clearance for the OASIS WOUND MATRIX. This device is classified as a Wound Dressing With Animal-derived Material(s).

Submitted by Cook Biotech, Inc. (West Lafayette, US). The FDA issued a Cleared decision on July 19, 2006, 30 days after receiving the submission on June 19, 2006.

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

Submission Details

510(k) Number	K061711 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 19, 2006
Decision Date	July 19, 2006
Days to Decision	30 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF