FDA 510(k) Application Details - K973899

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K973899
Device Name	Needle, Hypodermic, Single Lumen
Applicant	Owen Mumford USA, Inc. 849 PICKENS INDUSTRIAL DR. SUITE 14 MARIETTA, GA 30062 US Other 510(k) Applications for this Company
Contact	ROBERT E SHAW Other 510(k) Applications for this Contact
Regulation Number	880.5570   More FDA Info for this Regulation Number
Classification Product Code	FMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/14/1997
Decision Date	12/04/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review