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510(k) K000154

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2000
Date Received
January 19, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Larynx (Stents And Keels)
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
Submission Type

Other clearances by E. Benson Hood Lab, Inc.

  • K011329 — ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER (July 26, 2002)
  • K974132 — VOICE MASTER PROSTHESIS (February 25, 1998)

Other clearances for product code FWN

  • K091135 — RUTTER SUPRA STOMAL STENTS (September 14, 2009)
  • K962693 — MONTGOMERY RADIOPAQUE LARYNGEAL KEEL (August 9, 1996)
  • K896667 — LORENZ STENT (February 22, 1990)
  • K884810 — SILICONE LARYNGEAL STENT (May 10, 1989)
  • K864936 — 'EXMOOR' DAS GUPTA LARYNGEAL KEEL (April 27, 1987)
  • K853726 — LARYNGEAL (March 12, 1986)
  • K842800 — MONTG. LARYNGEAL KEEL (August 2, 1984)
  • K842287 — MONTGOMERY LARYNGEAL STENT (June 27, 1984)
  • K841347 — LARYNGEAL STENT (May 2, 1984)