Cleared Traditional

MCCONNELL ORTHOPEDIC ANTERIOR TORSO-ARM SUPPORT

K871820 · Mcconnell Orthopedic · General & Plastic Surgery

May 1987

Decision

15d

Days

Class 1

Risk

About This 510(k) Submission

K871820 is an FDA 510(k) clearance for the MCCONNELL ORTHOPEDIC ANTERIOR TORSO-ARM SUPPORT, a Operating Room Accessories Table Tray (Class I — General Controls, product code FWZ), submitted by Mcconnell Orthopedic (Dallas, US). The FDA issued a Cleared decision on May 26, 1987, 15 days after receiving the submission on May 11, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4950.

Submission Details

510(k) Number	K871820 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 11, 1987
Decision Date	May 26, 1987
Days to Decision	15 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—

Device Classification

Product Code	FWZ — Operating Room Accessories Table Tray
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4950
Definition	This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.