FDA 510(k) Application Details - K071150

Device Classification Name	Tube, Tympanostomy   More FDA Info for this Device
510(K) Number	K071150
Device Name	Tube, Tympanostomy
Applicant	HEINZ KURZ GMBH MEDIZINTECHNIK AMSTEL 320-1 AMSTERDAM D-72144 NL Other 510(k) Applications for this Company
Contact	DAGMAR MAESER Other 510(k) Applications for this Contact
Regulation Number	874.3880   More FDA Info for this Regulation Number
Classification Product Code	ETD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/25/2007
Decision Date	12/12/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review