FDA 510(k) Application Details - K012358

Device Classification Name	Kit, Needle, Biopsy   More FDA Info for this Device
510(K) Number	K012358
Device Name	Kit, Needle, Biopsy
Applicant	ISPG, INC. 517 LITCHFIELD RD. NEW MILFORD, CT 06776 US Other 510(k) Applications for this Company
Contact	LORETTA F LUHMAN 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	07/25/2001
Decision Date	10/15/2001
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