FDA 510(k) Application Details - K011755

Device Classification Name	Accessory, Surgical Apparel   More FDA Info for this Device
510(K) Number	K011755
Device Name	Accessory, Surgical Apparel
Applicant	STRYKER CORP. 4100 E. MILHAM AVE. KALAMAZOO, MI 49001 US Other 510(k) Applications for this Company
Contact	SUZANNE VELASQUEZ Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	LYU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/06/2001
Decision Date	06/22/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review