Cleared Traditional

NAGASHIMA SN-SP UNIT AND CHAIR

K822016 · Kelleher Corp. · Ear, Nose, Throat
Sep 1982
Decision
68d
Days
Class 1
Risk

About This 510(k) Submission

K822016 is an FDA 510(k) clearance for the NAGASHIMA SN-SP UNIT AND CHAIR, a Unit, Examining/treatment, Ent (Class I — General Controls, product code ETF), submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1982, 68 days after receiving the submission on July 8, 1982. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5300.

Submission Details

510(k) Number K822016 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 1982
Decision Date September 14, 1982
Days to Decision 68 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code ETF — Unit, Examining/treatment, Ent
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.5300

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