FDA 510(k) Application Details - K043063

Device Classification Name Dressing, Wound, Drug

  More FDA Info for this Device
510(K) Number K043063
Device Name Dressing, Wound, Drug
Applicant OXYBAND TECHNOLOGIES, INC.
5 TIMBER LANE
NORTH READING, MA 01864 US
Other 510(k) Applications for this Company
Contact MAUREEN O'CONNELL
Other 510(k) Applications for this Contact
Regulation Number 000.0000

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

  More FDA Info for this Product Code
Date Received 11/05/2004
Decision Date 03/24/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
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