FDA 510(k) Application Details - K042256

Device Classification Name Lamp, Infrared, Therapeutic Heating

  More FDA Info for this Device
510(K) Number K042256
Device Name Lamp, Infrared, Therapeutic Heating
Applicant USA LASER BIOTECH INC.
12101 CULLEN BLVD., # A
HOUSTON, TX 77047 US
Other 510(k) Applications for this Company
Contact M. JOYCE HEINRICH
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 08/20/2004
Decision Date 11/17/2004
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 N
Expedited Review



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