FDA 510(k) Application Details - K993895

Device Classification Name System,Planning,Radiation Therapy Treatment

  More FDA Info for this Device
510(K) Number K993895
Device Name System,Planning,Radiation Therapy Treatment
Applicant PERMEDICS, INC.
3722 SAUSALITO AVE.
IRVINE, CA 92606 US
Other 510(k) Applications for this Company
Contact GREG HOLLAND
Other 510(k) Applications for this Contact
Regulation Number 892.5050

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

  More FDA Info for this Product Code
Date Received 11/16/1999
Decision Date 06/02/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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