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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 K071150
Device Name TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE
Applicant
HEINZ KURZ GMBH MEDIZINTECHNIK
AMSTEL 320-1
AMSTERDAM,  NL D-72144
Applicant Contact DAGMAR MAESER
Correspondent
HEINZ KURZ GMBH MEDIZINTECHNIK
AMSTEL 320-1
AMSTERDAM,  NL D-72144
Correspondent Contact DAGMAR MAESER
Regulation Number874.3880
Classification Product Code
ETD  
Date Received04/25/2007
Decision Date 12/12/2007
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
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