510(k) K821993

Device: Shiley Laryngectomy Tube
Applicant: SHILEY, INC.
510(k) number: K821993
Product code: KAC
Decision: Substantially Equivalent (SESE)
Decision date: 1982-08-12
Date received: 1982-07-07
Regulation: 874.4420
Classification name: Tube, Laryngectomy
Medical specialty: Ear, Nose, Throat
Review panel: Ear, Nose, Throat
Device class: 1
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Address: 803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KAC#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K901377	BARTON-MAYO TRACHEOSTOMA BUTTON	Medical Innovations International, Inc.	1990-06-14
K873992	LARYNGECTOMY TUBE	Portex, Inc.	1988-03-24
K811428	NORTHWESTERN VOICE RESTORATION KIT	Universal Prosthetics, Inc.	1981-06-16