FDA 510(k) Application Details - K961407

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K961407
Device Name	Instrument, Biopsy
Applicant	GALLINI INTL., INC. 200 WINSTON DR., APT. L-11 CLIFFSIDE PARK, NJ 07010 US Other 510(k) Applications for this Company
Contact	CATERINA ELENA GALLUZZO 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	04/11/1996
Decision Date	11/21/1996
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