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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Ear Suction
510(k) Number K862903
Device Name MIDDLE EAR VIEWER AND FLUID COLLECTOR
Applicant
Steven K. Juhn
Gutenkauf
1300 Foshay Tower
Minneapolis,  MN  55402
Applicant Contact BARTZ &
Correspondent
Steven K. Juhn
Gutenkauf
1300 Foshay Tower
Minneapolis,  MN  55402
Correspondent Contact BARTZ &
Regulation Number874.4420
Classification Product Code
JZF  
Date Received07/31/1986
Decision Date 11/24/1986
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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