FDA 510(k) Application Details - K982260

Device Classification Name	Counter, Sponge, Surgical   More FDA Info for this Device
510(K) Number	K982260
Device Name	Counter, Sponge, Surgical
Applicant	MARKWELL INTL., INC. 2550 WEST MAIN ST. , SUITE 212 ALHAMBRA, CA 91801 US Other 510(k) Applications for this Company
Contact	SEAN WANG 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	06/26/1998
Decision Date	08/12/1998
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