FDA 510(k) Application Details - K012224

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K012224
Device Name	Instrument, Biopsy
Applicant	RANFAC CORP. 30 DOHERTY AVE., P.O. BOX 635 AVON INDUSTRIAL PARK AVON, MA 02322 US Other 510(k) Applications for this Company
Contact	GEORGE J HATTUB 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	06/16/2001
Decision Date	08/22/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review