FDA 510(k) Application Details - K090008

Device Classification Name Lamp, Infrared, Therapeutic Heating

  More FDA Info for this Device
510(K) Number K090008
Device Name Lamp, Infrared, Therapeutic Heating
Applicant PHAROS LIFE CORPORATION
11-380 JAMIESON PKWY
CAMBRIDGE, ONTARIO N3C 4N4 CA
Other 510(k) Applications for this Company
Contact PHIL CUSCUNA
Other 510(k) Applications for this Contact
Regulation Number 890.5500

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

  More FDA Info for this Product Code
Date Received 01/02/2009
Decision Date 10/15/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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