FDA 510(k) Application Details - K081323

Device Classification Name	Kit, Needle, Biopsy   More FDA Info for this Device
510(K) Number	K081323
Device Name	Kit, Needle, Biopsy
Applicant	B-K MEDICAL APS MILEPARKEN 34 HERLEV DK-2730 DK Other 510(k) Applications for this Company
Contact	JENS RASMUSSEN Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	FCG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/12/2008
Decision Date	07/22/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review