FDA 510(k) Application Details - K964113

Device Classification Name	Balloon, Epistaxis   More FDA Info for this Device
510(K) Number	K964113
Device Name	Balloon, Epistaxis
Applicant	M-PACT WORLDWIDE MANAGEMENT CORP. 1040 OCL PKWY. P.O. BOX 618 EUDORA, KS 66025 US Other 510(k) Applications for this Company
Contact	MARY SCHMALZ 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	10/15/1996
Decision Date	11/07/1996
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