Cleared Traditional

POLYVIOLENE SUTURE-REVISED LABELING

K926167 · Look, Inc. · General & Plastic Surgery
Dec 1993
Decision
381d
Days
Class 2
Risk

About This 510(k) Submission

K926167 is an FDA 510(k) clearance for the POLYVIOLENE SUTURE-REVISED LABELING, a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II — Special Controls, product code GAT), submitted by Look, Inc. (Ada, US). The FDA issued a Cleared decision on December 17, 1993, 381 days after receiving the submission on December 1, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5000.

Submission Details

510(k) Number K926167 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 1992
Decision Date December 17, 1993
Days to Decision 381 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code GAT — Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5000