FDA 510(k) Application Details - K100388

Device Classification Name	Light, Surgical, Fiberoptic   More FDA Info for this Device
510(K) Number	K100388
Device Name	Light, Surgical, Fiberoptic
Applicant	MEDICAL ILLUMINATION INTERNATIONAL, INC. 547 LIBRARY ST. SAN FERNANDO, CA 91340 US Other 510(k) Applications for this Company
Contact	WAYNE GEROW Other 510(k) Applications for this Contact
Regulation Number	878.4580   More FDA Info for this Regulation Number
Classification Product Code	FST Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/16/2010
Decision Date	06/22/2010
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