Cleared Traditional

K034039 - SIS PLASTIC SURGERY MATRIX
(FDA 510(k) Clearance)

K034039 · Cook Biotech, Inc. · General & Plastic Surgery device

Feb 2004

Decision

51d

Days

Class 2

Risk

K034039 is an FDA 510(k) clearance for the SIS PLASTIC SURGERY MATRIX. This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).

Submitted by Cook Biotech, Inc. (West Lafayette, US). The FDA issued a Cleared decision on February 18, 2004, 51 days after receiving the submission on December 29, 2003.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K034039 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 29, 2003
Decision Date	February 18, 2004
Days to Decision	51 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF