FDA 510(k) Application Details - K041077

Device Classification Name	Drape, Surgical   More FDA Info for this Device
510(K) Number	K041077
Device Name	Drape, Surgical
Applicant	IMALUX CORPORATION 1771 EAST 30TH STREET CLEVELAND, OH 44114 US Other 510(k) Applications for this Company
Contact	STEPHANIE A.S. HARRINGTON Other 510(k) Applications for this Contact
Regulation Number	878.4370   More FDA Info for this Regulation Number
Classification Product Code	KKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2004
Decision Date	06/25/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review