Cleared Traditional

SERRALENE, MODEL CATALOG NO 1S

K020265 · Serral, S.A. DE C.V. · General & Plastic Surgery
Mar 2002
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K020265 is an FDA 510(k) clearance for the SERRALENE, MODEL CATALOG NO 1S, a Suture, Nonabsorbable, Synthetic, Polypropylene (Class II — Special Controls, product code GAW), submitted by Serral, S.A. DE C.V. (Williamsburg, US). The FDA issued a Cleared decision on March 8, 2002, 42 days after receiving the submission on January 25, 2002. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5010.

Submission Details

510(k) Number K020265 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2002
Decision Date March 08, 2002
Days to Decision 42 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code GAW — Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5010