Cleared Traditional

SPOON

K854894 · Euro-Med Intl. · General & Plastic Surgery
May 1986
Decision
147d
Days
Class 1
Risk

About This 510(k) Submission

K854894 is an FDA 510(k) clearance for the SPOON, a Instrument, Surgical, Disposable (Class I — General Controls, product code KDC), submitted by Euro-Med Intl. (Danville, US). The FDA issued a Cleared decision on May 2, 1986, 147 days after receiving the submission on December 6, 1985. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K854894 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 1985
Decision Date May 02, 1986
Days to Decision 147 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

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

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