FDA 510(k) Application Details - K062610

Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)

  More FDA Info for this Device
510(K) Number K062610
Device Name Pump, Portable, Aspiration (Manual Or Powered)
Applicant OHIO MEDICAL CORPORATION
1111 LAKESIDE DR.
GURNEE, IL 60031 US
Other 510(k) Applications for this Company
Contact HOBY CHAE
Other 510(k) Applications for this Contact
Regulation Number 878.4780

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

  More FDA Info for this Product Code
Date Received 09/05/2006
Decision Date 09/28/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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