FDA 510(k) Application Details - K020577

Device Classification Name Catheter, Ureteral, Gastro-Urology

  More FDA Info for this Device
510(K) Number K020577
Device Name Catheter, Ureteral, Gastro-Urology
Applicant APPLIED MEDICAL RESOURCES CORP.
22872 Avenida Empresa
Rancho Santa Margarita, CA 92688 US
Other 510(k) Applications for this Company
Contact ANIL BHALANI
Other 510(k) Applications for this Contact
Regulation Number 876.5130

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

  More FDA Info for this Product Code
Date Received 02/21/2002
Decision Date 05/22/2002
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 N
Expedited Review



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