Cleared Traditional

ARM BOARD W/I.V COVERING

K823412 · Sage Products, Inc. · General & Plastic Surgery
Dec 1982
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K823412 is an FDA 510(k) clearance for the ARM BOARD W/I.V COVERING, a Board, Arm (with Cover), Sterile (Class I — General Controls, product code BTX), submitted by Sage Products, Inc. (Walker, US). The FDA issued a Cleared decision on December 15, 1982, 30 days after receiving the submission on November 15, 1982. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3910.

Submission Details

510(k) Number K823412 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 1982
Decision Date December 15, 1982
Days to Decision 30 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code BTX — Board, Arm (with Cover), Sterile
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.3910