FDA 510(k) Application Details - K091462

Device Classification Name	Handle, Scalpel   More FDA Info for this Device
510(K) Number	K091462
Device Name	Handle, Scalpel
Applicant	SPECTRA, INC. 260 F&H FORDHAM ROAD WILMINGTON, MA 01887 US Other 510(k) Applications for this Company
Contact	AGUSTIN TURRIZA Other 510(k) Applications for this Contact
Regulation Number	878.4800   More FDA Info for this Regulation Number
Classification Product Code	GDZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/2009
Decision Date	12/15/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review