FDA 510(k) Application Details - K070924

Device Classification Name Powered Laser Surgical Instrument

  More FDA Info for this Device
510(K) Number K070924
Device Name Powered Laser Surgical Instrument
Applicant ALLMED SYSTEMS INC.
9232 KLEMETSON DRIVE
PLEASANTON, CA 94588 US
Other 510(k) Applications for this Company
Contact PETER ALLEN
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 04/03/2007
Decision Date 06/21/2007
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