Cleared Traditional

FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C

K071353 · Shanghai Foshion Medical Instruments Co., Ltd. · Dental
Dec 2007
Decision
213d
Days
Class 1
Risk

About This 510(k) Submission

K071353 is an FDA 510(k) clearance for the FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C, a Chair, Dental, With Operative Unit (Class I — General Controls, product code KLC), submitted by Shanghai Foshion Medical Instruments Co., Ltd. (Leola, US). The FDA issued a Cleared decision on December 14, 2007, 213 days after receiving the submission on May 15, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.6250.

Submission Details

510(k) Number K071353 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2007
Decision Date December 14, 2007
Days to Decision 213 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KLC — Chair, Dental, With Operative Unit
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6250