FDA 510(k) Application Details - K052952

Device Classification Name Accessories, Catheter, G-U

  More FDA Info for this Device
510(K) Number K052952
Device Name Accessories, Catheter, G-U
Applicant PHYSICIAN TECHNOLOGIES, INC.
4932 EAST HOLBROOK STREET
ANAHEIM, CA 92807-1154 US
Other 510(k) Applications for this Company
Contact RANDALL MAY
Other 510(k) Applications for this Contact
Regulation Number 876.5130

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

  More FDA Info for this Product Code
Date Received 10/20/2005
Decision Date 05/14/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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