FDA 510(k) Application Details - K080158

Device Classification Name	Expander, Surgical, Skin Graft   More FDA Info for this Device
510(K) Number	K080158
Device Name	Expander, Surgical, Skin Graft
Applicant	LB MEDICAL L.L.C. 901 KING STREET, SUITE 200 ALEXANDRIA, VA 22314 US Other 510(k) Applications for this Company
Contact	TERRY SHERIDAN POWELL Other 510(k) Applications for this Contact
Regulation Number	878.4800   More FDA Info for this Regulation Number
Classification Product Code	FZW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/23/2008
Decision Date	05/02/2008
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