FDA 510(k) Application Details - K053227

Device Classification Name Light, Surgical, Fiberoptic

  More FDA Info for this Device
510(K) Number K053227
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 MIKE ALCALA
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 11/17/2005
Decision Date 01/13/2006
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact