FDA 510(k) Application Details - K990645

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K990645
Device Name	Instrument, Biopsy
Applicant	GALLINI U.S., LLC. 3991 GLENSIDE DR., SUITE F RICHMOND, VA 23229 US Other 510(k) Applications for this Company
Contact	PAUL L HAWTHORNE 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	02/26/1999
Decision Date	05/19/1999
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