FDA 510(k) Application Details - K061316

Device Classification Name	Counter, Sponge, Surgical   More FDA Info for this Device
510(K) Number	K061316
Device Name	Counter, Sponge, Surgical
Applicant	MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE MUNDELEIN, IL 60060 US Other 510(k) Applications for this Company
Contact	LARA N SIMMONS Other 510(k) Applications for this Contact
Regulation Number	880.2740   More FDA Info for this Regulation Number
Classification Product Code	LWH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/11/2006
Decision Date	11/02/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review