FDA 510(k) Application Details - K013511

Device Classification Name	Light, Surgical, Endoscopic   More FDA Info for this Device
510(K) Number	K013511
Device Name	Light, Surgical, Endoscopic
Applicant	ACULUX, INC. 273 SOUTH AIRPORT PULLING RD. NAPLES, FL 34104 US Other 510(k) Applications for this Company
Contact	KIM MARSH Other 510(k) Applications for this Contact
Regulation Number	878.4580   More FDA Info for this Regulation Number
Classification Product Code	FSW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/22/2001
Decision Date	02/01/2002
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