FDA 510(k) Application Details - K101468

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K101468
Device Name	Gown, Surgical
Applicant	3M COMPANY CORP 3M CENTER, BLDG 275-5W-06 ST. PAUL, MN 55144-1000 US Other 510(k) Applications for this Company
Contact	LINDA JOHNSON 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	05/27/2010
Decision Date	04/14/2011
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