FDA 510(k) Application Details - K973085

Device Classification Name	Balloon, Epistaxis   More FDA Info for this Device
510(K) Number	K973085
Device Name	Balloon, Epistaxis
Applicant	ULTRACELL MEDICAL TECHNOLOGIES, INC. 183 PROVIDENCE,NEW LONDON TNPK P.O. BOX 326 NORTH STONINGTON, CT 06359 US Other 510(k) Applications for this Company
Contact	GEORGE P KORTEWEG 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	08/18/1997
Decision Date	11/18/1997
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