Cleared Traditional

LITHOTOMY CHAIR #415

K831385 · Midmark Corp. · General & Plastic Surgery
Jun 1983
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K831385 is an FDA 510(k) clearance for the LITHOTOMY CHAIR #415, a Chair, Surgical, Ac-powered (Class I — General Controls, product code GBB), submitted by Midmark Corp. (Walker, US). The FDA issued a Cleared decision on June 2, 1983, 35 days after receiving the submission on April 28, 1983. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number K831385 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 1983
Decision Date June 02, 1983
Days to Decision 35 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GBB — Chair, Surgical, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4960