FDA 510(k) Application Details - K974229

Device Classification Name Powered Laser Surgical Instrument

  More FDA Info for this Device
510(K) Number K974229
Device Name Powered Laser Surgical Instrument
Applicant LASER PERIPHERALS LLC.
5484 FELTL RD.
MINNETONKA, MN 55343 US
Other 510(k) Applications for this Company
Contact NANCY L ARNOLD
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 11/12/1997
Decision Date 02/10/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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