Cleared Traditional

K792281 - USHER'S MARLEX TUBULAR MESH (FDA 510(k) Clearance)

K792281 · Davol, Inc. · General & Plastic Surgery device

Nov 1979

Decision

14d

Days

Class 2

Risk

K792281 is an FDA 510(k) clearance for the USHER'S MARLEX TUBULAR MESH. This device is classified as a Mesh, Surgical, Polymeric (Class II - Special Controls, product code FTL).

Submitted by Davol, Inc. (Walker, US). The FDA issued a Cleared decision on November 27, 1979, 14 days after receiving the submission on November 13, 1979.

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

Submission Details

510(k) Number	K792281 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 13, 1979
Decision Date	November 27, 1979
Days to Decision	14 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—