FDA 510(k) Application Details - K080795

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K080795
Device Name	Gown, Surgical
Applicant	KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. BLDG 300, #1092 ROSWELL, GA 30076-2199 US Other 510(k) Applications for this Company
Contact	DAVID M LEE Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FYA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/20/2008
Decision Date	09/03/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review