Cleared Traditional

K042026 - BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004 (FDA 510(k) Clearance)

K042026 · C.R. Bard, Inc. · General & Plastic Surgery device

Sep 2004

Decision

44d

Days

Class 2

Risk

K042026 is an FDA 510(k) clearance for the BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004. 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 September 10, 2004, 44 days after receiving the submission on July 28, 2004.

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

Submission Details

510(k) Number	K042026 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 28, 2004
Decision Date	September 10, 2004
Days to Decision	44 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF