Cleared Traditional

DUALUME LARYNGEAL EXAMINATION TELESCOPE

K790845 · National Medical Technology · Ear, Nose, Throat

Jul 1979

Decision

81d

Days

Class 2

Risk

About This 510(k) Submission

K790845 is an FDA 510(k) clearance for the DUALUME LARYNGEAL EXAMINATION TELESCOPE, a Telescope, Laryngeal-bronchial (Class II — Special Controls, product code ENZ), submitted by National Medical Technology (Mchenry, US). The FDA issued a Cleared decision on July 24, 1979, 81 days after receiving the submission on May 4, 1979. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K790845 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 04, 1979
Decision Date	July 24, 1979
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—

Device Classification

Product Code	ENZ — Telescope, Laryngeal-bronchial
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4680
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).