FDA 510(k) Application Details - K983647

Device Classification Name	Device, Percutaneous, Biopsy   More FDA Info for this Device
510(K) Number	K983647
Device Name	Device, Percutaneous, Biopsy
Applicant	STS BIOPOLYMERS 12300 TWINBROOK PKWY. SUITE 625 ROCKVILLE, MD 20852 US Other 510(k) Applications for this Company
Contact	T. WHIT ATHEY Other 510(k) Applications for this Contact
Regulation Number	878.4800   More FDA Info for this Regulation Number
Classification Product Code	MJG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/16/1998
Decision Date	01/20/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review