FDA 510(k) Application Details - K983276

Device Classification Name	Balloon, Epistaxis   More FDA Info for this Device
510(K) Number	K983276
Device Name	Balloon, Epistaxis
Applicant	HYDROFERA, LLC. 322 MAIN ST., SUITE 1101 WILLIMANTIC, CT 06226 US Other 510(k) Applications for this Company
Contact	HEATHER S BOND 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	09/17/1998
Decision Date	09/14/1999
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