FDA 510(k) Application Details - K983296

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K983296
Device Name	Instrument, Biopsy
Applicant	UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. NORWALK, CT 06856 US Other 510(k) Applications for this Company
Contact	CHRISTOPHER A GRAHAM 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	09/21/1998
Decision Date	06/04/1999
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