FDA 510(k) Application Details - K083330

Device Classification Name	Kit, Needle, Biopsy   More FDA Info for this Device
510(K) Number	K083330
Device Name	Kit, Needle, Biopsy
Applicant	COOK ENDOSCOPY 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. WINSTON-SALEM, NC 27105 US Other 510(k) Applications for this Company
Contact	SCOTTIE FARIOLE 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	11/12/2008
Decision Date	02/06/2009
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