FDA 510(k) Application Details - K041446

Device Classification Name	Balloon, Epistaxis   More FDA Info for this Device
510(K) Number	K041446
Device Name	Balloon, Epistaxis
Applicant	LES LABORATORIRES BROTHIER, S.A. 41 RUE DE NEUILLY NANTERRE PARIS FR Other 510(k) Applications for this Company
Contact	RICHARD J FREER, PH.D. Other 510(k) Applications for this Contact
Regulation Number	874.4100   More FDA Info for this Regulation Number
Classification Product Code	EMX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2004
Decision Date	07/01/2004
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