FDA 510(k) Application Details - K981889

Device Classification Name	Kit, Needle, Biopsy   More FDA Info for this Device
510(K) Number	K981889
Device Name	Kit, Needle, Biopsy
Applicant	WORLDWIDE MEDICAL TECHNOLOGIES, LLC 125 MAIN ST., NORTH WOODBURY, CT 06798-0505 US Other 510(k) Applications for this Company
Contact	GARY A LAMOUREUX 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	05/29/1998
Decision Date	07/31/1998
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