FDA 510(k) Application Details - K100099

Device Classification Name Tube, Feeding

  More FDA Info for this Device
510(K) Number K100099
Device Name Tube, Feeding
Applicant PHILIPS CHILDREN'S MEDICAL VENTURES
191 WYNGATE DRIVE
MONROEVILLE, PA 15146 US
Other 510(k) Applications for this Company
Contact LISA CASAVANT
Other 510(k) Applications for this Contact
Regulation Number 876.5980

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

  More FDA Info for this Product Code
Date Received 01/13/2010
Decision Date 06/14/2010
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