Cleared Traditional

A.C.L. GUIDE KIT

K862564 · Aspen Laboratories, Inc. · General & Plastic Surgery
Aug 1986
Decision
46d
Days
Class 1
Risk

About This 510(k) Submission

K862564 is an FDA 510(k) clearance for the A.C.L. GUIDE KIT, a Guide, Surgical, Instrument (Class I — General Controls, product code FZX), submitted by Aspen Laboratories, Inc. (Englewood, US). The FDA issued a Cleared decision on August 18, 1986, 46 days after receiving the submission on July 3, 1986. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K862564 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 1986
Decision Date August 18, 1986
Days to Decision 46 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FZX — Guide, Surgical, Instrument
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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