FDA 510(k) Application Details - K080005

Device Classification Name Apparatus, Suction, Ward Use, Portable, Ac-Powered

  More FDA Info for this Device
510(K) Number K080005
Device Name Apparatus, Suction, Ward Use, Portable, Ac-Powered
Applicant DING HWA CO., LTD.
NO. 6, LANE 29, WENMING RD.
GUISHAN, TAOYUAN TW
Other 510(k) Applications for this Company
Contact HUI-CHEN KAI
Other 510(k) Applications for this Contact
Regulation Number 878.4780

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

  More FDA Info for this Product Code
Date Received 01/02/2008
Decision Date 04/24/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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