FDA 510(k) Application Details - K092800

Device Classification Name Powered Light Based Non-Laser Surgical Instrument

  More FDA Info for this Device
510(K) Number K092800
Device Name Powered Light Based Non-Laser Surgical Instrument
Applicant LED INTELLECTUAL PROPERTIES, LLC
1131 ANTHEM VIEW LANE
KNOXVILLE, TN 37922 US
Other 510(k) Applications for this Company
Contact ROBERT T WAGNER
Other 510(k) Applications for this Contact
Regulation Number 878.4810

  More FDA Info for this Regulation Number
Classification Product Code ONE
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 09/11/2009
Decision Date 02/04/2010
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



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