Cleared Abbreviated

CYTOPLAST PTFE SUTURE

K072076 · Osteogenics Biomedical, Inc. · General & Plastic Surgery

Oct 2007

Decision

93d

Days

Class 2

Risk

About This 510(k) Submission

K072076 is an FDA 510(k) clearance for the CYTOPLAST PTFE SUTURE, a Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (Class II — Special Controls, product code NBY), submitted by Osteogenics Biomedical, Inc. (Lubbock, US). The FDA issued a Cleared decision on October 31, 2007, 93 days after receiving the submission on July 30, 2007. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5035.

Submission Details

510(k) Number	K072076 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 30, 2007
Decision Date	October 31, 2007
Days to Decision	93 days
Submission Type	Abbreviated
Review Panel	General & Plastic Surgery (SU)
Summary	Statement

Device Classification

Product Code	NBY — Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.5035