Cleared Traditional

K944937 - SYNTHETIC ABSORBABLE SUTURE
(FDA 510(k) Clearance)

K944937 · Johnson & Johnson International · General & Plastic Surgery
May 1995
Decision
225d
Days
Class 2
Risk

K944937 is an FDA 510(k) clearance for the SYNTHETIC ABSORBABLE SUTURE, a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II — Special Controls, product code GAM), submitted by Johnson & Johnson International (Raynham, US). The FDA issued a Cleared decision on May 19, 1995, 225 days after receiving the submission on October 6, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4493.

Submission Details

510(k) Number K944937 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 1994
Decision Date May 19, 1995
Days to Decision 225 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4493

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