FDA 510(k) Application Details - K072539

Device Classification Name Catheter, Straight

  More FDA Info for this Device
510(K) Number K072539
Device Name Catheter, Straight
Applicant CURE MEDICAL LLC.
28241 CROWN VALLEY PARKWAY
SUITE 510
LAGUNA NIGUEL, CA 92677 US
Other 510(k) Applications for this Company
Contact James Smith
Other 510(k) Applications for this Contact
Regulation Number 876.5130

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

  More FDA Info for this Product Code
Date Received 09/10/2007
Decision Date 09/13/2007
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