Cleared Traditional

K002684 - COMPOSIX E/X MESH (FDA 510(k) Clearance)

K002684 · C.R. Bard, Inc. · General & Plastic Surgery device

Oct 2000

Decision

44d

Days

Class 2

Risk

K002684 is an FDA 510(k) clearance for the COMPOSIX E/X MESH. This device is classified as a Mesh, Surgical, Polymeric (Class II - Special Controls, product code FTL).

Submitted by C.R. Bard, Inc. (Canston, US). The FDA issued a Cleared decision on October 11, 2000, 44 days after receiving the submission on August 28, 2000.

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

Submission Details

510(k) Number	K002684 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 28, 2000
Decision Date	October 11, 2000
Days to Decision	44 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF