FDA 510(k) Application Details - K140588

Device Classification Name	Hood, Surgical   More FDA Info for this Device
510(K) Number	K140588
Device Name	Hood, Surgical
Applicant	STRYKER CORPORATION 4100 E. MILHAM AVE KALAMAZOO, MI 49001 US Other 510(k) Applications for this Company
Contact	JULIA HELGESON Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FXY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/07/2014
Decision Date	06/26/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review