Cleared Traditional

OEC DESIGN ORTHOPEDIC CAST HEEL

K864092 · Military Engineering, Inc. · Orthopedic
Dec 1986
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K864092 is an FDA 510(k) clearance for the OEC DESIGN ORTHOPEDIC CAST HEEL, a Component, Cast (Class I — General Controls, product code LGF), submitted by Military Engineering, Inc. (Plymouth, US). The FDA issued a Cleared decision on December 16, 1986, 56 days after receiving the submission on October 21, 1986. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.5940.

Submission Details

510(k) Number K864092 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1986
Decision Date December 16, 1986
Days to Decision 56 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code LGF — Component, Cast
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.5940