Cleared Traditional

K020732 - SS MATRIX
(FDA 510(k) Clearance)

K020732 · Cook Biotech, Inc. · General & Plastic Surgery device

May 2002

Decision

85d

Days

—

Risk

K020732 is an FDA 510(k) clearance for the SS 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 May 30, 2002, 85 days after receiving the submission on March 6, 2002.

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

Submission Details

510(k) Number	K020732 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 06, 2002
Decision Date	May 30, 2002
Days to Decision	85 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF