Cleared Traditional

SURGICAL INSTRUMENT KIT, DISPOSABLE

K923176 · Ulti-Med Intl., Inc. · General & Plastic Surgery
Jun 1993
Decision
370d
Days
Class 1
Risk

About This 510(k) Submission

K923176 is an FDA 510(k) clearance for the SURGICAL INSTRUMENT KIT, DISPOSABLE, a Kit, Surgical Instrument, Disposable (Class I — General Controls, product code KDD), submitted by Ulti-Med Intl., Inc. (Glendale Hts., US). The FDA issued a Cleared decision on June 17, 1993, 370 days after receiving the submission on June 12, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K923176 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 1992
Decision Date June 17, 1993
Days to Decision 370 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

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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