FDA 510(k) Application Details - K980588

Device Classification Name	Retractor   More FDA Info for this Device
510(K) Number	K980588
Device Name	Retractor
Applicant	CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 MINNEAPOLIS, MN 55427-8656 US Other 510(k) Applications for this Company
Contact	DALE SAPPENFIELD Other 510(k) Applications for this Contact
Regulation Number	878.4800   More FDA Info for this Regulation Number
Classification Product Code	GAD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/17/1998
Decision Date	08/18/1998
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