FDA 510(k) Application Details - K092227

Device Classification Name	Rongeur, Manual   More FDA Info for this Device
510(K) Number	K092227
Device Name	Rongeur, Manual
Applicant	INTEGRA LIFESCIENCES CORP. 589 DAVIES DR. YORK, PA 17402 US Other 510(k) Applications for this Company
Contact	JENNIFER BOSLEY Other 510(k) Applications for this Contact
Regulation Number	882.4840   More FDA Info for this Regulation Number
Classification Product Code	HAE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/23/2009
Decision Date	02/17/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review