Cleared Traditional

POLYVIOLENE SURGICL SUTURE

K943949 · Look, Inc. · General & Plastic Surgery
Nov 1994
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K943949 is an FDA 510(k) clearance for the POLYVIOLENE SURGICL SUTURE, 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 November 10, 1994, 100 days after receiving the submission on August 2, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5000.

Submission Details

510(k) Number K943949 FDA.gov
FDA Decision Cleared SN
Date Received August 02, 1994
Decision Date November 10, 1994
Days to Decision 100 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

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