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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Laryngectomy
510(k) Number K901377
Device Name BARTON-MAYO TRACHEOSTOMA BUTTON
Applicant
Medical Innovations International, Inc.
3105 NW 22nd St.
Rochester,  MN  55901
Applicant Contact TODD J HEIN
Correspondent
Medical Innovations International, Inc.
3105 NW 22nd St.
Rochester,  MN  55901
Correspondent Contact TODD J HEIN
Regulation Number874.4420
Classification Product Code
KAC  
Date Received03/22/1990
Decision Date 06/14/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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