Cleared Traditional

NON-ABSORBABLE SURGICAL SUTURES

K930517 · Alcon Laboratories · General & Plastic Surgery
Dec 1993
Decision
319d
Days
Class 2
Risk

About This 510(k) Submission

K930517 is an FDA 510(k) clearance for the NON-ABSORBABLE SURGICAL SUTURES, a Suture, Nonabsorbable, Synthetic, Polyamide (Class II — Special Controls, product code GAR), submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on December 17, 1993, 319 days after receiving the submission on February 1, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5020.

Submission Details

510(k) Number K930517 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 1993
Decision Date December 17, 1993
Days to Decision 319 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code GAR — Suture, Nonabsorbable, Synthetic, Polyamide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5020

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