FDA 510(k) Application Details - K032242

Device Classification Name	Blade, Scalpel   More FDA Info for this Device
510(K) Number	K032242
Device Name	Blade, Scalpel
Applicant	OMI MANUFACTURING PTY., LTD. PO BOX 7007 DEERFIELD, IL 60015 US Other 510(k) Applications for this Company
Contact	DANIEL KAMM Other 510(k) Applications for this Contact
Regulation Number	878.4800   More FDA Info for this Regulation Number
Classification Product Code	GES Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/21/2003
Decision Date	09/23/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review