FDA 510(k) Application Details - K973786

Device Classification Name System, Applicator, Radionuclide, Manual

  More FDA Info for this Device
510(K) Number K973786
Device Name System, Applicator, Radionuclide, Manual
Applicant NW RADIATION THERAPY PRODUCTS
5245 SHILSHOLE AVENUE NW,
SUITE B
SEATTLE,, WA 98107 US
Other 510(k) Applications for this Company
Contact TERENCE ELLARD
Other 510(k) Applications for this Contact
Regulation Number 892.5650

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

  More FDA Info for this Product Code
Date Received 10/06/1997
Decision Date 01/02/1998
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