FDA 510(k) Application Details - K133008

Device Classification Name	Kit, Needle, Biopsy   More FDA Info for this Device
510(K) Number	K133008
Device Name	Kit, Needle, Biopsy
Applicant	BEACON ENDOSCOPIC 2000 COMMONWEALTH AVE STE 110 AUBURNDALE, MA 02466 US Other 510(k) Applications for this Company
Contact	ANNETTE M FAGNANT 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	09/25/2013
Decision Date	11/20/2013
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