FDA 510(k) Application Details - K962568

Device Classification Name	Kit, Needle, Biopsy   More FDA Info for this Device
510(K) Number	K962568
Device Name	Kit, Needle, Biopsy
Applicant	GALLINI INTL., INC. 1454 ROCKAWAY PKWY., SUITE 300 BROOKLYN, NY 11236 US Other 510(k) Applications for this Company
Contact	CATERINA E GALLUZZO Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	FCG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/1996
Decision Date	11/25/1996
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