FDA 510(k) Application Details - K003636

Device Classification Name Accelerator, Linear, Medical

  More FDA Info for this Device
510(K) Number K003636
Device Name Accelerator, Linear, Medical
Applicant VARIAN MEDICAL SYSTEMS, INC.
3100 HANSEN WAY
PALO ALTO, CA 94304-1129 US
Other 510(k) Applications for this Company
Contact LINDA S NASH
Other 510(k) Applications for this Contact
Regulation Number 892.5050

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

  More FDA Info for this Product Code
Date Received 11/24/2000
Decision Date 02/02/2001
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