Cleared Traditional

ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1

K000154 · E. Benson Hood Lab, Inc. · Ear, Nose, Throat

Mar 2000

Decision

70d

Days

Class 2

Risk

About This 510(k) Submission

K000154 is an FDA 510(k) clearance for the ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1, a Prosthesis, Larynx (stents And Keels) (Class II — Special Controls, product code FWN), submitted by E. Benson Hood Lab, Inc. (Pembroke, US). The FDA issued a Cleared decision on March 29, 2000, 70 days after receiving the submission on January 19, 2000. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number	K000154 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 19, 2000
Decision Date	March 29, 2000
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF