FDA 510(k) Application Details - K963856

Device Classification Name	Balloon, Epistaxis   More FDA Info for this Device
510(K) Number	K963856
Device Name	Balloon, Epistaxis
Applicant	RAND SCIENTIFIC CORP. 4135 NORTHGATE BLVD., SUITE 9 SACRAMENTO, CA 95834 US Other 510(k) Applications for this Company
Contact	DUANE TRACY 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	09/25/1996
Decision Date	10/18/1996
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