FDA 510(k) Application Details - K022169

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K022169
Device Name	Instrument, Biopsy
Applicant	PARALLAX MEDICAL, INC. 940 DISC DR. SCOTTS VALLEY, CA 95066-4544 US Other 510(k) Applications for this Company
Contact	RICHARD M RUEDY 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	07/03/2002
Decision Date	07/25/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review