FDA 510(k) Application Details - K961208

Device Classification Name Accelerator, Linear, Medical

  More FDA Info for this Device
510(K) Number K961208
Device Name Accelerator, Linear, Medical
Applicant PTW-NEW YORK CORP.
2437 GRAND AVE.
BELLMORE, NY 11710 US
Other 510(k) Applications for this Company
Contact STEPHEN R SZEGLIN
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 03/26/1996
Decision Date 06/17/1996
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