FDA 510(k) Application Details - K000135

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K000135
Device Name	Instrument, Biopsy
Applicant	PRO.DUCT HEALTH, INC. 1010 HAMILTON CT. MENLO PARK, CA 94025 US Other 510(k) Applications for this Company
Contact	ANGELA B SOITO 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	01/18/2000
Decision Date	04/10/2000
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