Cleared Traditional

SERRALESTER

K020902 · Serral, S.A. DE C.V. · General & Plastic Surgery
May 2002
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K020902 is an FDA 510(k) clearance for the SERRALESTER, a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II — Special Controls, product code GAT), submitted by Serral, S.A. DE C.V. (Williamsburg, US). The FDA issued a Cleared decision on May 20, 2002, 61 days after receiving the submission on March 20, 2002. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5000.

Submission Details

510(k) Number K020902 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 2002
Decision Date May 20, 2002
Days to Decision 61 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