Cleared Traditional

K102766 - COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM (FDA 510(k) Clearance)

K102766 · C.R. Bard, Inc. · General & Plastic Surgery device

Dec 2010

Decision

83d

Days

Class 2

Risk

K102766 is an FDA 510(k) clearance for the COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM. This device is classified as a Mesh, Surgical, Polymeric (Class II - Special Controls, product code FTL).

Submitted by C.R. Bard, Inc. (Warwick, US). The FDA issued a Cleared decision on December 16, 2010, 83 days after receiving the submission on September 24, 2010.

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

Submission Details

510(k) Number	K102766 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 24, 2010
Decision Date	December 16, 2010
Days to Decision	83 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF