FDA 510(k) Application Details - K971411

Device Classification Name	Balloon, Epistaxis   More FDA Info for this Device
510(K) Number	K971411
Device Name	Balloon, Epistaxis
Applicant	BENTEC MEDICAL, INC. 4234 NORTH FREEWAY BLVD. SACRAMENTO, CA 95834 US Other 510(k) Applications for this Company
Contact	LOU MATSON 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	04/16/1997
Decision Date	06/03/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review