FDA 510(k) Application Details - K961402

Device Classification Name	Mask, Surgical   More FDA Info for this Device
510(K) Number	K961402
Device Name	Mask, Surgical
Applicant	INNOVATIVE OUTSOURCING SOLUTIONS 51 MIDDLESEX ST. NORTH CHELMSFORD, MA 01863 US Other 510(k) Applications for this Company
Contact	LAWRENCE A RUCKI Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FXX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/1996
Decision Date	07/12/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review