Cleared Traditional

712 PLASTIC SURGERY TABLE & ACCESORIES

K915141 · Midmark Corp. · General & Plastic Surgery
Jan 1992
Decision
57d
Days
Class 1
Risk

About This 510(k) Submission

K915141 is an FDA 510(k) clearance for the 712 PLASTIC SURGERY TABLE & ACCESORIES, a Table, Operating-room, Ac-powered (Class I — General Controls, product code FQO), submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on January 9, 1992, 57 days after receiving the submission on November 13, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number K915141 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1991
Decision Date January 09, 1992
Days to Decision 57 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code FQO — Table, Operating-room, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4960