FDA 510(k) Application Details - K061375

Device Classification Name	Respirator,Surgical   More FDA Info for this Device
510(K) Number	K061375
Device Name	Respirator,Surgical
Applicant	LOUIS M. GERSON CO., INC. 15 SPROAT ST. MIDDLEBORO, MA 02346 US Other 510(k) Applications for this Company
Contact	ROBERT BRUNELL Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	MSH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/17/2006
Decision Date	11/17/2006
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