510(k) K000154

ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 by E. Benson Hood Lab, Inc. — Product Code FWN

K000154 is an FDA 510(k) premarket notification submitted by E. Benson Hood Lab, Inc. for the device "ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1". The FDA issued a decision of Substantially Equivalent on March 29, 2000. The device falls under product code FWN (Prosthesis, Larynx (Stents And Keels)), a Class II device regulated under 21 CFR 874.3620. E. Benson Hood Lab, Inc. has at least 2 other 510(k) clearances on record.