Cleared Traditional

WILLIAMS BELT & BOOT

K891387 · Arthro-Medic, Inc. · General & Plastic Surgery

May 1989

Decision

70d

Days

Class 1

Risk

About This 510(k) Submission

K891387 is an FDA 510(k) clearance for the WILLIAMS BELT & BOOT, a Table, Surgical With Orthopedic Accessories, Manual (Class I — General Controls, product code JEB), submitted by Arthro-Medic, Inc. (Jacksonville, US). The FDA issued a Cleared decision on May 23, 1989, 70 days after receiving the submission on March 14, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4950.

Submission Details

510(k) Number	K891387 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 1989
Decision Date	May 23, 1989
Days to Decision	70 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—