Cleared Traditional

NAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGL

K821706 · Kelleher Corp. · Ear, Nose, Throat

Jun 1982

Decision

16d

Days

Class 2

Risk

About This 510(k) Submission

K821706 is an FDA 510(k) clearance for the NAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGL, a Laryngoscope, Nasopharyngoscope (Class II — Special Controls, product code EQN), submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on June 25, 1982, 16 days after receiving the submission on June 9, 1982. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K821706 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 09, 1982
Decision Date	June 25, 1982
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—

Device Classification

Product Code	EQN — Laryngoscope, Nasopharyngoscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4760
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).