Cleared Traditional

STERILE SUTURE REMOVAL SET

K832047 · Ormed Mfg., Inc. · General & Plastic Surgery
Sep 1983
Decision
80d
Days
Class 1
Risk

About This 510(k) Submission

K832047 is an FDA 510(k) clearance for the STERILE SUTURE REMOVAL SET, a Kit, Surgical Instrument, Disposable (Class I — General Controls, product code KDD), submitted by Ormed Mfg., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983, 80 days after receiving the submission on June 24, 1983. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K832047 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 1983
Decision Date September 12, 1983
Days to Decision 80 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code KDD — Kit, Surgical Instrument, Disposable
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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