FDA 510(k) Application Details - K033666

Device Classification Name

  More FDA Info for this Device
510(K) Number K033666
Device Name HEMADERM
Applicant MEDAFOR, INC.
2700 FREEWAY BLVD
SUITE 800
MINNEAPOLIS, MN 55430 US
Other 510(k) Applications for this Company
Contact JENNIFER A MAY
Other 510(k) Applications for this Contact
Regulation Number

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

  More FDA Info for this Product Code
Date Received 11/21/2003
Decision Date 12/17/2003
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