FDA 510(k) Application Details - K140137

Device Classification Name	Kit, Needle, Biopsy   More FDA Info for this Device
510(K) Number	K140137
Device Name	Kit, Needle, Biopsy
Applicant	PFM MEDICAL, INC 1815 ASTON AVE, SUITE 106 CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	SALVADORE PALOMARES 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	01/22/2014
Decision Date	03/25/2014
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	Y
Expedited Review