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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tympanostomy
510(k) Number K973226
Device Name TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T)
Applicant
Heinz Kurz GmbH Medizintechnik
Tubinger Strasse 3
Dusslingen,  DE D-72144
Applicant Contact DAGMAR S MASER
Correspondent
Heinz Kurz GmbH Medizintechnik
Tubinger Strasse 3
Dusslingen,  DE D-72144
Correspondent Contact DAGMAR S MASER
Regulation Number874.3880
Classification Product Code
ETD  
Date Received08/27/1997
Decision Date 11/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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