Cleared Traditional

MEDALIST EXAMINATION TABLE

K883680 · Hamilton Industries, Inc. · General Hospital
Oct 1988
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K883680 is an FDA 510(k) clearance for the MEDALIST EXAMINATION TABLE, a Table, Examination, Medical, Powered (Class I — General Controls, product code LGX), submitted by Hamilton Industries, Inc. (Two Rivers, US). The FDA issued a Cleared decision on October 4, 1988, 36 days after receiving the submission on August 29, 1988. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number K883680 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 1988
Decision Date October 04, 1988
Days to Decision 36 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code LGX — Table, Examination, Medical, Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4960