FDA 510(k) Application Details - K981374

Device Classification Name	Splint, Intranasal Septal   More FDA Info for this Device
510(K) Number	K981374
Device Name	Splint, Intranasal Septal
Applicant	POREX SURGICAL, INC. 4715 ROOSEVELT HWY. COLLEGE PARK, GA 30349-2417 US Other 510(k) Applications for this Company
Contact	HOWARD A MERCER Other 510(k) Applications for this Contact
Regulation Number	874.4780   More FDA Info for this Regulation Number
Classification Product Code	LYA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/16/1998
Decision Date	07/02/1998
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