Cleared Traditional

OP-CON SURG. INSTRUMENT #7

K834172 · Imm Enterprises , Ltd. · Ear, Nose, Throat

Mar 1984

Decision

106d

Days

Class 2

Risk

About This 510(k) Submission

K834172 is an FDA 510(k) clearance for the OP-CON SURG. INSTRUMENT #7, a Laryngoscope, Nasopharyngoscope (Class II — Special Controls, product code EQN), submitted by Imm Enterprises , Ltd. (Mchenry, US). The FDA issued a Cleared decision on March 6, 1984, 106 days after receiving the submission on November 21, 1983. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K834172 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 21, 1983
Decision Date	March 06, 1984
Days to Decision	106 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).