FDA 510(k) Application Details - K050957

Device Classification Name	Instrument, Manual, Surgical, General Use   More FDA Info for this Device
510(K) Number	K050957
Device Name	Instrument, Manual, Surgical, General Use
Applicant	SPECIAL DEVICES, INC. 12493 OLD ROUGH AND READY HWY. GRASS VALLEY, CA 95945 US Other 510(k) Applications for this Company
Contact	JOSEPH J SPRANZA III Other 510(k) Applications for this Contact
Regulation Number	878.4800   More FDA Info for this Regulation Number
Classification Product Code	MDM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/15/2005
Decision Date	05/18/2005
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	N
Expedited Review