FDA 510(k) Application Details - K080247

Device Classification Name	Splint, Intranasal Septal   More FDA Info for this Device
510(K) Number	K080247
Device Name	Splint, Intranasal Septal
Applicant	Z-MEDICA CORPORATION 4 FAIRFIELD BLVD. WALLINGFORD, CT 06492 US Other 510(k) Applications for this Company
Contact	RONALD E PETERSON 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	01/31/2008
Decision Date	02/27/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review