FDA 510(k) Application Details - K020729

Device Classification Name Powered Laser Surgical Instrument

  More FDA Info for this Device
510(K) Number K020729
Device Name Powered Laser Surgical Instrument
Applicant ICN PHOTONICS LTD.
UNITS 1 & 2,HEOL RHOSYN
DAFEN PARC
LLANELLI, CARMARTHENSHIRE SA14 8QG GB
Other 510(k) Applications for this Company
Contact IAN MORTIMER
Other 510(k) Applications for this Contact
Regulation Number 878.4810

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

  More FDA Info for this Product Code
Date Received 03/06/2002
Decision Date 06/04/2002
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