FDA 510(k) Application Details - K153306

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K153306
Device Name	Instrument, Biopsy
Applicant	ORTHOVITA, INC. 45 GREAT VALLEY PARKWAY MALVERN, PA 19355 US Other 510(k) Applications for this Company
Contact	LYNN LUNDY Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	KNW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/16/2015
Decision Date	12/18/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review