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510(k) K901377

Device
BARTON-MAYO TRACHEOSTOMA BUTTON
Applicant
MEDICAL INNOVATIONS INTERNATIONAL, INC.
510(k) number
K901377
Product code
KAC  
Decision
Substantially Equivalent (SESE)
Decision date
1990-06-14
Date received
1990-03-22
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#

Contact
TODD J HEIN
Address
3105 NW 22nd St. Rochester MN US 55901 55901

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
K873992LARYNGECTOMY TUBEPortex, Inc.1988-03-24
K821993SHILEY LARYNGECTOMY TUBEShiley, Inc.1982-08-12
K811428NORTHWESTERN VOICE RESTORATION KITUniversal Prosthetics, Inc.1981-06-16

Legacy Summary#

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FDA Review#

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