Cleared Traditional

UNIVERSALLY ADJUSTABLE ARMBOARD

K882524 · Karlin Technology, Inc. · General & Plastic Surgery
Jul 1988
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K882524 is an FDA 510(k) clearance for the UNIVERSALLY ADJUSTABLE ARMBOARD, a Board, Arm (with Cover), Sterile (Class I — General Controls, product code BTX), submitted by Karlin Technology, Inc. (Marina Del Rey, US). The FDA issued a Cleared decision on July 8, 1988, 21 days after receiving the submission on June 17, 1988. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3910.

Submission Details

510(k) Number K882524 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 1988
Decision Date July 08, 1988
Days to Decision 21 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