FDA 510(k) Application Details - K070692

Device Classification Name	Respirator,Surgical   More FDA Info for this Device
510(K) Number	K070692
Device Name	Respirator,Surgical
Applicant	DUKAL CORPORATION 5 PLANT AVENUE HAUPPAUGE, NY 11788 US Other 510(k) Applications for this Company
Contact	PATRICK J LAMB 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	03/13/2007
Decision Date	05/30/2007
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