FDA 510(k) Application Details - K973656

Device Classification Name	Balloon, Epistaxis   More FDA Info for this Device
510(K) Number	K973656
Device Name	Balloon, Epistaxis
Applicant	SPECIALTY SURGICAL PRODUCTS, INC. 302 NORTH FIRST ST. HAMILTON, MT 59840 US Other 510(k) Applications for this Company
Contact	T. JAN VARNER 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	09/25/1997
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