FDA 510(k) Application Details - K192362

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K192362
Device Name	Gown, Surgical
Applicant	O&M Halyard, Inc. 9120 Lockwood Blvd Mechanicsville, VA 23116 US Other 510(k) Applications for this Company
Contact	Kimberly Lewis 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	08/30/2019
Decision Date	12/13/2019
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