FDA 510(k) Application Details - K110724

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K110724
Device Name	Gown, Surgical
Applicant	OMNIA SPA 11460 N MERIDIAN STREET SUITE 150 CARMEL, IN 46032 US Other 510(k) Applications for this Company
Contact	JAMIE AUSTIN 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	03/16/2011
Decision Date	06/23/2011
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