FDA 510(k) Application Details - K960228

Device Classification Name	Balloon, Epistaxis   More FDA Info for this Device
510(K) Number	K960228
Device Name	Balloon, Epistaxis
Applicant	SHIPPERT MEDICAL TECHNOLOGIES CORP. 7002 SOUTH REVERE PARKWAY, SUITE 60 ENGLEWOOD, CO 80112 US Other 510(k) Applications for this Company
Contact	SARAH M LAKE 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	01/17/1996
Decision Date	02/27/1996
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