FDA 510(k) Application Details - K060673

Device Classification Name Stent, Ureteral

  More FDA Info for this Device
510(K) Number K060673
Device Name Stent, Ureteral
Applicant APPLIED MEDICAL RESOURCES CORP.
22872 Avenida Empresa
Rancho Santa Margarita, CA 92688 US
Other 510(k) Applications for this Company
Contact CHERYL BLAKE
Other 510(k) Applications for this Contact
Regulation Number 876.4620

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

  More FDA Info for this Product Code
Date Received 03/14/2006
Decision Date 03/29/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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