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510(k) K811428

Device
NORTHWESTERN VOICE RESTORATION KIT
Applicant
UNIVERSAL PROSTHETICS, INC.
510(k) number
K811428
Product code
KAC  
Decision
Substantially Equivalent (SESE)
Decision date
1981-06-16
Date received
1981-05-22
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)DeviceApplicantDecision date
K901377BARTON-MAYO TRACHEOSTOMA BUTTONMedical Innovations International, Inc.1990-06-14
K873992LARYNGECTOMY TUBEPortex, Inc.1988-03-24
K821993SHILEY LARYNGECTOMY TUBEShiley, Inc.1982-08-12

Legacy Summary#

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FDA Review#

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