FDA 510(k) Application Details - K102923

Device Classification Name	Respirator,Surgical   More FDA Info for this Device
510(K) Number	K102923
Device Name	Respirator,Surgical
Applicant	MOLNLYCKE HEALTHCARE 5550 PEACHTREE PARKWAY SUITE 500 NORCROSS, GA 30092 US Other 510(k) Applications for this Company
Contact	CAITLIN SENTER 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	10/01/2010
Decision Date	11/19/2010
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