FDA 510(k) Application Details - K052279

Device Classification Name Endoscopic Cytology Brush

  More FDA Info for this Device
510(K) Number K052279
Device Name Endoscopic Cytology Brush
Applicant COOK IRELAND LTD
O'HALLORAN ROAD
NATIONAL TECHNOLOGICAL PARK
LIMERICK IE
Other 510(k) Applications for this Company
Contact EMMETT DEVEREUX
Other 510(k) Applications for this Contact
Regulation Number 876.1500

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

  More FDA Info for this Product Code
Date Received 08/22/2005
Decision Date 10/11/2005
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