Cleared Traditional

NAGASHIMA SN OPERATOR'S CHAIR

K822264 · Kelleher Corp. · General & Plastic Surgery
Oct 1982
Decision
76d
Days
Class 1
Risk

About This 510(k) Submission

K822264 is an FDA 510(k) clearance for the NAGASHIMA SN OPERATOR'S CHAIR, a Chair, Surgical, Ac-powered (Class I — General Controls, product code GBB), submitted by Kelleher Corp. (Walker, US). The FDA issued a Cleared decision on October 13, 1982, 76 days after receiving the submission on July 29, 1982. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number K822264 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1982
Decision Date October 13, 1982
Days to Decision 76 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