FDA 510(k) Application Details - K200493

Device Classification Name	Hood, Surgical   More FDA Info for this Device
510(K) Number	K200493
Device Name	Hood, Surgical
Applicant	Stryker Corporation 4100 E. Milham Avenue Kalamazoo, MI 49001 US Other 510(k) Applications for this Company
Contact	Corinne Larke-Grass 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	02/28/2020
Decision Date	03/21/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review