Cleared Traditional

JARIT RECOMMENDED SINUS INSTRUMENTS

K944670 · J. Jamner Surgical Instruments, Inc. · Ear, Nose, Throat

Feb 1995

Decision

133d

Days

Class 2

Risk

About This 510(k) Submission

K944670 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 February 2, 1995, 133 days after receiving the submission on September 22, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K944670 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 1994
Decision Date	February 02, 1995
Days to Decision	133 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).