FDA 510(k) Application Details - K993362

Device Classification Name	Balloon, Epistaxis   More FDA Info for this Device
510(K) Number	K993362
Device Name	Balloon, Epistaxis
Applicant	BIOMATRIX, INC. 65 RAILROAD AVE. RIDGEFIELD, NJ 07657 US Other 510(k) Applications for this Company
Contact	MARIO J RERES 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	10/06/1999
Decision Date	03/13/2000
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