FDA 510(k) Application Details - K012532

Device Classification Name	Splint, Intranasal Septal   More FDA Info for this Device
510(K) Number	K012532
Device Name	Splint, Intranasal Septal
Applicant	GENZYME CORP. 1125 PLEASANT VIEW TERRANCE RIDGEFIELD, NJ 07657 US Other 510(k) Applications for this Company
Contact	NANCY A IMMEL 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	08/06/2001
Decision Date	10/30/2001
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