FDA 510(k) Application Details - K060268

Device Classification Name Catheter, Urethral

  More FDA Info for this Device
510(K) Number K060268
Device Name Catheter, Urethral
Applicant CLAY KENNARD
2909 BROWNE STONE ROAD
OKLAHOMA CITY, OK 73120 US
Other 510(k) Applications for this Company
Contact CLAY KENNARD
Other 510(k) Applications for this Contact
Regulation Number 876.5130

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

  More FDA Info for this Product Code
Date Received 02/01/2006
Decision Date 02/24/2006
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 N
Expedited Review



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