Cleared Traditional

JARIT RECOMMENDED SINUS INSTRUMENTS

K941565 · J. Jamner Surgical Instruments, Inc. · Ear, Nose, Throat

May 1994

Decision

45d

Days

Class 2

Risk

About This 510(k) Submission

K941565 is an FDA 510(k) clearance for the JARIT RECOMMENDED SINUS INSTRUMENTS, a Nasopharyngoscope (flexible Or Rigid) (Class II — Special Controls, product code EOB), submitted by J. Jamner Surgical Instruments, Inc. (Hawthorne, US). The FDA issued a Cleared decision on May 16, 1994, 45 days after receiving the submission on April 1, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K941565 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 01, 1994
Decision Date	May 16, 1994
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement

Device Classification

Product Code	EOB — Nasopharyngoscope (flexible Or Rigid)
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).