FDA 510(k) Application Details - K112945

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K112945
Device Name	Instrument, Biopsy
Applicant	INRAD INC. 4375 DONKER CT SE GRAND RAPIDS, MI 49504 US Other 510(k) Applications for this Company
Contact	RYAN GOOSEN 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	10/04/2011
Decision Date	11/03/2011
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