FDA 510(k) Application Details - K100551

Device Classification Name	Counter, Sponge, Surgical   More FDA Info for this Device
510(K) Number	K100551
Device Name	Counter, Sponge, Surgical
Applicant	HALDOR ADVANCED TECHNOLOGIES LTD 107 SHAVEY TZION PARDES HANNA 37052 IL Other 510(k) Applications for this Company
Contact	SARIT GELBART GAL-ROM 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	02/26/2010
Decision Date	08/12/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review