Cleared Traditional

K896946 - COATED NOVAFIL, POLYBUTESTER, MESH
(FDA 510(k) Clearance)

K896946 · American Cyanamid Co. · General & Plastic Surgery device

May 1990

Decision

145d

Days

Class 2

Risk

K896946 is an FDA 510(k) clearance for the COATED NOVAFIL, POLYBUTESTER, MESH. This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).

Submitted by American Cyanamid Co. (Danbury, US). The FDA issued a Cleared decision on May 7, 1990, 145 days after receiving the submission on December 13, 1989.

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

Submission Details

510(k) Number	K896946 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 13, 1989
Decision Date	May 07, 1990
Days to Decision	145 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—