FDA 510(k) Application Details - K070431

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K070431
Device Name	Gown, Surgical
Applicant	WELMED INC. 1340 WEST PENNSYLVANIA AVENUE SAN DIEGO, CA 92103 US Other 510(k) Applications for this Company
Contact	Glen Feye 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	02/13/2007
Decision Date	05/24/2007
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